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Class 2 Device Recall EtCO2 Module |
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| Date Initiated by Firm |
June 23, 2016 |
| Create Date |
October 11, 2018 |
| Recall Status1 |
Terminated 3 on November 16, 2016 |
| Recall Number |
Z-2388-2016 |
| Recall Event ID |
74632 |
| 510(K)Number |
K113623 K131971 K110922 K113653
|
| Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
|
| Product |
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors
EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The Patient Monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates, such as ECG, Respiration (RESP), IBP, NIBP, Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). |
| Code Information |
Part Number Model Serial Number Country 83.60.000703 iM80 000703-M16401550001 Poland 83.60.001840 iM8B 001840-M16401570001 India 83.60.001840 iM8B 001840-M16401570002 India 83.60.001840 iM8B 001840-M16401570003 India 83.60.001840 iM8B 001840-M16401570004 India 83.60.001840 iM8B 001840-M16401570005 India 83.60.001840 iM8B 001840-M16401570006 India 83.60.001840 iM8B 001840-M16401570007 India 83.60.001840 iM8B 001840-M16401570008 India 83.60.002371 IM70 002371-M16306180001 China 83.60.260047 iM70 260047-M16201960001 South Africa 83.60.260047 iM70 260047-M16309400001 Pakistan 83.60.260047 iM70 260047-M16309400002 Pakistan 83.60.260047 iM70 260047-M16309400003 Sudan 83.60.260047 iM70 260047-M16309400004 Pakistan 83.60.260047 iM70 260047-M16309400005 Pakistan 83.60.260047 iM70 260047-M16500950001 Argentina 83.60.260047 iM70 260047-M16500980001 Saudi Arabia 83.60.260047 iM70 260047-M16500980002 Saudi Arabia 83.60.260047 iM70 260047-M16500980003 Saudi Arabia 83.60.260047 iM70 260047-M16603490001 Uruguay 83.60.260047 iM70 260047-M16603490002 Uruguay 83.60.260062 IM70 260062-M16301290001 China 83.60.260062 IM70 260062-M16403280001 China 83.60.260062 IM70 260062-M16502120001 China 83.60.260062 IM70 260062-M16502120002 China 83.60.260062 IM70 260062-M16502120003 China 83.60.260062 IM70 260062-M16502120004 China 83.60.260062 IM70 260062-M16502120005 China 83.60.260062 IM70 260062-M16502120006 China 83.60.260062 IM70 260062-M16604600001 China 83.60.260092 iM8A 260092-M16410820001 Guatemala 83.60.260111 iM60 260111-M16506880001 USA 83.60.260117 iM8B 260117-M16409440001 China 83.60.260140 iM8B 260140-M16405850001 India 83.60.260140 iM8B 260140-M16405850002 India 83.60.260140 iM8B 260140-M16405850003 India 83.60.260168 iM8 260168-M16404550001 Turkey 83.60.260168 iM8 260168-M16404550002 Turkey 83.60.260168 iM8 260168-M16404550003 Turkey 83.60.260168 iM8 260168-M16404550004 Turkey 83.60.260168 iM8 260168-M16404550005 Turkey 83.60.260168 iM8 260168-M16404550006 Turkey 83.60.260168 iM8 260168-M16404550007 Turkey 83.60.260168 iM8 260168-M16404550008 Turkey 83.60.260168 iM8 260168-M16404550009 Turkey 83.60.260168 iM8 260168-M16404550010 Turkey 83.60.260168 iM8 260168-M16404550011 Turkey 83.60.260168 iM8 260168-M16404550012 Turkey 83.60.260168 iM8 260168-M16404550013 Turkey 83.60.260168 iM8 260168-M16404550014 Turkey 83.60.260168 iM8 260168-M16404550015 Turkey 83.60.260168 iM8 260168-M16404550016 Turkey 83.60.260168 iM8 260168-M16404550017 Turkey 83.60.260168 iM8 260168-M16404550018 Turkey 83.60.260168 iM8 260168-M16404550019 Turkey 83.60.260168 iM8 260168-M16404550020 Turkey 83.60.260251 iM60 260251-M16203740001 Nicaragua 83.60.260251 iM60 260251-M16304660001 P eople's Democratic Republic 83.60.260251 iM60 260251-M16304660002 P eople's Democratic Republic 83.60.260253 iM50 260253-M16301210001 South Africa 83.60.260266 iM60 260266-M16203930001 USA 83.60.260266 iM60 260266-M16203930002 USA 83.60.260266 iM60 260266-M16203930003 USA 83.60.260266 iM60 260266-M16203930004 USA 83.60.260266 iM60 260266-M16203930005 USA 83.60.260266 iM60 260266-M16203930006 USA 83.60.260266 iM60 260266-M16203930007 USA 83.60.260266 iM60 260266-M16203930008 USA 83.60.260266 iM60 260266-M16203930009 USA 83.60.260266 iM60 260266-M16203930010 USA 83.60.260266 iM60 260266-M16203930011 USA 83.60.260266 iM60 260266-M16203930012 USA 83.60.260266 iM60 260266-M16203930013 USA 83.60.260266 iM60 260266-M16203930014 USA 83.60.260266 iM60 260266-M16203930015 USA 83.60.260266 iM60 260266-M16307780001 USA 83.60.260266 iM60 260266-M16307780002 USA 83.60.260266 iM60 260266-M16307780003 USA 83.60.260266 iM60 260266-M16307780004 USA 83.60.260266 iM60 260266-M16307780005 USA 83.60.260266 iM60 260266-M16307780006 USA 83.60.260266 iM60 260266-M16307780007 USA 83.60.260266 iM60 260266-M16307780008 USA 83.60.260266 iM60 260266-M16307780009 USA 83.60.260266 iM60 260266-M16307780010 USA 83.60.260266 iM60 260266-M16307780011 USA 83.60.260266 iM60 260266-M16307780012 USA 83.60.260266 iM60 260266-M16307780013 USA 83.60.260266 iM60 260266-M16307780014 USA 83.60.260266 iM60 260266-M16307780015 USA 83.60.260380 iM50 260380-M16204910001 India 83.60.260380 iM50 260380-M16510000001 Sri Lanka 83.60.260424 iM70 260424-M16205120001 Colombia 83.60.260424 iM70 260424-M16205120002 Colombia 83.60.260424 iM70 260424-M16205120003 Colombia 83.60.260424 iM70 260424-M16205120004 Colombia 83.60.260424 iM70 260424-M16205120005 Colombia 83.60.260424 iM70 260424-M16205120006 Colombia 83.60.260424 iM70 260424-M16205120007 Colombia 83.60.260424 iM70 260424-M16205120008 Colombia 83.60.260424 iM70 260424-M16205120009 Colombia 83.60.260424 iM70 260424-M16205120010 Colombia 83.60.260424 iM70 260424-M16205120011 Colombia 83.60.260424 iM70 260424-M16205120012 Colombia 83.60.260424 iM70 260424-M16205120013 Colombia 83.60.260424 iM70 260424-M16205120014 Colombia 83.60.260424 iM70 260424-M16205120015 Colombia 83.60.260445 iM50 260445-M16508990001 USA 83.60.260445 iM50 260445-M16508990002 USA 83.60.260445 iM50 260445-M16508990003 USA 83.60.260536 iM80 260536-M16503370001 India 83.60.260536 iM80 260536-M16503370002 India 83.60.260536 iM80 260536-M16503370003 India 83.60.260536 iM80 260536-M16503370004 India 83.60.260536 iM80 260536-M16503370005 India 83.60.260536 iM80 260536-M16503370006 India 83.60.260536 iM80 260536-M16503370007 India 83.60.260536 iM80 260536-M16506640001 China 83.60.260536 iM80 260536-M16506640002 China 83.60.260536 iM80 260536-M16506640003 China 83.60.260618 iM80 260618-M16403150001 Thailand 83.60.260626 iM50 260626-M16201370002 Germany 83.60.260626 iM50 260626-M16500900001 Germany 83.60.260626 iM50 260626-M16500900002 Germany 83.60.260645 iM8 260645-M16203940001 USA 83.60.260645 iM8 260645-M16203940002 USA 83.60.260645 iM8 260645-M16203940003 USA 83.60.260645 iM8 260645-M16203940004 USA 83.60.260645 iM8 260645-M16203940005 USA 83.60.260645 iM8 260645-M16203940006 USA 83.60.260645 iM8 260645-M16203940007 USA 83.60.260645 iM8 260645-M16203940008 USA 83.60.260645 iM8 260645-M16203940009 USA 83.60.260645 iM8 260645-M16203940010 USA 83.60.260645 iM8 260645-M16203940011 USA 83.60.260645 iM8 260645-M16203940012 USA 83.60.260645 iM8 260645-M16314850001 USA 83.60.260645 iM8 260645-M16314850002 USA 83.60.260645 iM8 260645-M16314850003 USA 83.60.260645 iM8 260645-M16314850004 USA 83.60.260645 iM8 260645-M16314850005 USA 83.60.260645 iM8 260645-M16406980001 USA 83.60.260645 iM8 260645-M16406980002 USA 83.60.260645 iM8 260645-M16406980003 USA 83.60.260645 iM8 260645-M16406980004 USA 83.60.260645 iM8 260645-M16406980005 USA 83.60.260645 iM8 260645-M16406980006 USA 83.60.260645 iM8 260645-M16406980007 USA 83.60.260645 iM8 260645-M16406980008 USA 83.60.260645 iM8 260645-M16406980009 USA 83.60.260645 iM8 260645-M16406980010 USA 83.60.260645 iM8 260645-M16406980011 USA 83.60.260645 iM8 260645-M16406980012 USA 83.60.260645 iM8 260645-M16406980013 USA 83.60.260645 iM8 260645-M16406980014 USA 83.60.260645 iM8 260645-M16406980015 USA 83.60.260645 iM8 260645-M16406980016 USA 83.60.260645 iM8 260645-M16406980017 USA 83.60.260645 iM8 260645-M16406980018 USA 83.60.260645 iM8 260645-M16406980019 USA 83.60.260645 iM8 260645-M16406980020 USA 83.60.260645 iM8 260645-M16407130001 USA 83.60.260645 iM8 260645-M16407130002 USA 83.60.260645 iM8 260645-M16407130003 USA 83.60.260645 iM8 260645-M16407130004 USA 83.60.260645 iM8 260645-M16407130005 USA 83.60.260645 iM8 260645-M16407130006 USA 83.60.260645 iM8 260645-M16407130007 USA 83.60.260645 iM8 260645-M16407130008 USA 83.60.260645 iM8 260645-M16407130009 USA 83.60.260645 iM8 260645-M16407130010 USA 83.60.260645 iM8 260645-M16407130011 USA 83.60.260645 iM8 260645-M16407130012 USA 83.60.260645 iM8 260645-M16407130013 USA 83.60.260645 iM8 260645-M16407130014 USA 83.60.260645 iM8 260645-M16407130015 USA 83.60.260645 iM8 260645-M16407130016 USA 83.60.260645 iM8 260645-M16407130017 USA 83.60.260645 iM8 260645-M16407130018 USA 83.60.260645 iM8 260645-M16407130019 USA 83.60.260645 iM8 260645-M16407130020 USA 83.60.260645 iM8 260645-M16407130021 USA 83.60.260645 iM8 260645-M16407130022 USA 83.60.260645 iM8 260645-M16407130023 USA 83.60.260645 iM8 260645-M16407130024 USA 83.60.260645 iM8 260645-M16407130025 USA 83.60.260645 iM8 260645-M16407130026 USA 83.60.260645 iM8 260645-M16407130027 USA 83.60.260645 iM8 260645-M16407130028 USA 83.60.260645 iM8 260645-M16407130029 USA 83.60.260645 iM8 260645-M16407130030 USA 83.60.260672 iM80A 260672-M16408200001 China 83.60.260675 iM50 260675-M16205100001 Senegal 83.60.260675 iM50 260675-M16205100002 Senegal 83.60.260675 iM50 260675-M16205100003 Senegal 83.60.260675 iM50 260675-M16205100004 Senegal 83.60.260675 iM50 260675-M16205100005 Senegal 83.60.260675 iM50 260675-M16205100006 Senegal 83.60.260675 iM50 260675-M16205100007 Senegal 83.60.260675 iM50 260675-M16205100008 Senegal 83.60.260680 iM60 260680-M16311910001 Nicaragua 83.60.260680 iM60 260680-M16311910002 Nicaragua 83.60.260680 iM60 260680-M16311910003 Nicaragua 83.60.260680 iM60 260680-M16311910004 Nicaragua 83.60.260680 iM60 260680-M16311910005 Nicaragua 83.60.260680 iM60 260680-M16311910006 Nicaragua 83.60.260680 iM60 260680-M16311910007 Nicaragua 83.60.260680 iM60 260680-M16311910008 Nicaragua 83.60.260680 iM60 260680-M16311910009 Nicaragua 83.60.260680 iM60 260680-M16311910010 Nicaragua 83.60.260680 iM60 260680-M16311910011 Nicaragua 83.60.260680 iM60 260680-M16311910012 Nicaragua 83.60.260680 iM60 260680-M16311910013 Nicaragua 83.60.260680 iM60 260680-M16311910014 Nicaragua 83.60.260680 iM60 260680-M16311910015 Nicaragua 83.60.260680 iM60 260680-M16311910016 Nicaragua 83.60.260680 iM60 260680-M16311910017 Nicaragua 83.60.260680 iM60 260680-M16311910018 Nicaragua 83.60.260680 iM60 260680-M16311910019 Nicaragua 83.60.260680 iM60 260680-M16311910020 Nicaragua 83.60.260680 iM60 260680-M16311910021 Nicaragua 83.60.260680 iM60 260680-M16311910022 Nicaragua 83.60.260680 iM60 260680-M16311910023 Nicaragua 83.60.260680 iM60 260680-M16311910024 Nicaragua 83.60.260680 iM60 260680-M16311910025 Nicaragua 83.60.260680 iM60 260680-M16311910026 Nicaragua 83.60.260680 iM60 260680-M16311910027 Nicaragua 83.60.260680 iM60 260680-M16311910028 Nicaragua 83.60.260680 iM60 260680-M16311910029 Nicaragua 83.60.260680 iM60 260680-M16311910030 Nicaragua 83.60.260680 iM60 260680-M16311910031 Nicaragua 83.60.260711 iM60 260711-M16203750001 Nepal 83.60.260711 iM60 260711-M16203750003 Nepal 83.60.260711 iM60 260711-M16203750005 Nepal 83.60.260711 iM60 260711-M16203750006 Nepal 83.60.260711 iM60 260711-M16203750007 Nepal 83.60.260712 iM50 260712-M16202660001 Senegal 83.60.260712 iM50 260712-M16202660002 Senegal 83.60.260718 iM50 260718-M16302840001 China 83.60.260719 M50 260719-M16302860001 Russia 83.60.260721 M50 260721-M16304860001 Germany 83.60.260721 M50 260721-M16304860002 Germany 83.60.260721 M50 260721-M16304860003 Germany 83.60.260724 iM60 260724-M16305050001 USA 83.60.260724 iM60 260724-M16305050002 USA 83.60.260724 iM60 260724-M16305050003 USA 83.60.260724 iM60 260724-M16305050004 USA 83.60.260724 iM60 260724-M16305050005 USA 83.60.260724 iM60 260724-M16305050006 USA 83.60.260724 iM60 260724-M16305050007 USA 83.60.260724 iM60 260724-M16305050008 USA 83.60.260724 iM60 260724-M16305050009 USA 83.60.260724 iM60 260724-M16305050010 USA 83.60.260724 iM60 260724-M16305050011 USA 83.60.260724 iM60 260724-M16305050012 USA 83.60.260724 iM60 260724-M16305050013 USA 83.60.260724 iM60 260724-M16305050014 USA 83.60.260724 iM60 260724-M16305050015 USA 83.60.260724 iM60 260724-M16305050016 USA 83.60.260724 iM60 260724-M16305050017 USA 83.60.260724 iM60 260724-M16305050018 USA 83.60.260724 iM60 260724-M16305050019 USA 83.60.260724 iM60 260724-M16305050020 USA 83.60.260724 iM60 260724-M16305050021 USA 83.60.260724 iM60 260724-M16305050022 USA 83.60.260724 iM60 260724-M16305050023 USA 83.60.260724 iM60 260724-M16305050024 USA 83.60.260724 iM60 260724-M16305050025 USA 83.60.260724 iM60 260724-M16305050026 USA 83.60.260724 iM60 260724-M16305050027 USA 83.60.260724 iM60 260724-M16305050028 USA 83.60.260724 iM60 260724-M16305050029 USA 83.60.260724 iM60 260724-M16305050030 USA 83.60.260724 iM60 260724-M16305050031 USA 83.60.260724 iM60 260724-M16305050032 USA 83.60.260724 iM60 260724-M16305050033 USA 83.60.260724 iM60 260724-M16305050034 USA 83.60.260724 iM60 260724-M16305050035 USA 83.60.260724 iM60 260724-M16305050036 USA 83.60.260724 iM60 260724-M16305050037 USA 83.60.260724 iM60 260724-M16305050038 USA 83.60.260724 iM60 260724-M16305050039 USA 83.60.260724 iM60 260724-M16305050040 USA 83.60.260724 iM60 260724-M16305050041 USA 83.60.260724 iM60 260724-M16305050042 USA 83.60.260724 iM60 260724-M16305050043 USA 83.60.260724 iM60 260724-M16305050044 USA 83.60.260724 iM60 260724-M16305050045 USA 83.60.260724 iM60 260724-M16305050046 USA 83.60.260724 iM60 260724-M16305050047 USA 83.60.260724 iM60 260724-M16305050048 USA 83.60.260724 iM60 260724-M16305050049 USA 83.60.260724 iM60 260724-M16305050050 USA 83.60.260724 iM60 260724-M16305050051 USA 83.60.260724 iM60 260724-M16305050052 USA 83.60.260724 iM60 260724-M16305050053 USA 83.60.260724 iM60 260724-M16305050054 USA 83.60.260724 iM60 260724-M16305050055 USA 83.60.260724 iM60 260724-M16305050056 USA 83.60.260724 iM60 260724-M16305050057 USA 83.60.260724 iM60 260724-M16305050058 USA 83.60.260724 iM60 260724-M16305050059 USA 83.60.260724 iM60 260724-M16305050060 USA 83.60.260724 iM60 260724-M16305050061 USA 83.60.260724 iM60 260724-M16305050062 USA 83.60.260724 iM60 260724-M16305050063 USA 83.60.260724 iM60 260724-M16305050064 USA 83.60.260724 iM60 260724-M16305050065 USA 83.60.260724 iM60 260724-M16305050066 USA 83.60.260724 iM60 260724-M16305050067 USA 83.60.260724 iM60 260724-M16305050068 USA 83.60.260724 iM60 260724-M16305050069 USA 83.60.260724 iM60 260724-M16305050070 USA 83.60.260724 iM60 260724-M16305050071 USA 83.60.260724 iM60 260724-M16305050072 USA 83.60.260724 iM60 260724-M16305050073 USA 83.60.260724 iM60 260724-M16305050074 USA 83.60.260724 iM60 260724-M16305050075 USA 83.60.260724 iM60 260724-M16305050076 USA 83.60.260724 iM60 260724-M16305050077 USA 83.60.260724 iM60 260724-M16305050078 USA 83.60.260724 iM60 260724-M16305050079 USA 83.60.260724 iM60 260724-M16305050080 USA 83.60.260724 iM60 260724-M16305050081 USA 83.60.260724 iM60 260724-M16305050082 USA 83.60.260724 iM60 260724-M16305050083 USA 83.60.260724 iM60 260724-M16305050084 USA 83.60.260724 iM60 260724-M16305050085 USA 83.60.260724 iM60 260724-M16305050086 USA 83.60.260724 iM60 260724-M16305050087 USA 83.60.260724 iM60 260724-M16305050088 USA 83.60.260724 iM60 260724-M16305050089 USA 83.60.260724 iM60 260724-M16305050090 USA 83.60.260724 iM60 260724-M16305050091 USA 83.60.260724 iM60 260724-M16305050092 USA 83.60.260724 iM60 260724-M16305050093 USA 83.60.260724 iM60 260724-M16305050094 USA 83.60.260724 iM60 260724-M16305050095 USA 83.60.260724 iM60 260724-M16305050096 USA 83.60.260724 iM60 260724-M16305050097 USA 83.60.260724 iM60 260724-M16305050098 USA 83.60.260724 iM60 260724-M16305050099 USA 83.60.260724 iM60 260724-M16305050100 USA 83.60.260724 iM60 260724-M16603500001 USA 83.60.260724 iM60 260724-M16603500002 USA 83.60.260724 iM60 260724-M16603500003 USA 83.60.260724 iM60 260724-M16603500004 USA 83.60.260724 iM60 260724-M16603500005 USA 83.60.260724 iM60 260724-M16603500006 USA 83.60.260724 iM60 260724-M16603500007 USA 83.60.260724 iM60 260724-M16603500008 USA 83.60.260724 iM60 260724-M16603500009 USA 83.60.260724 iM60 260724-M16603500010 USA 83.60.260724 iM60 260724-M16603500011 USA 83.60.260724 iM60 260724-M16603500012 USA 83.60.260724 iM60 260724-M16603500013 USA 83.60.260724 iM60 260724-M16603500014 USA 83.60.260724 iM60 260724-M16603500015 USA 83.60.260736 iM70 260736-M16309420001 Italy 83.60.260736 iM70 260736-M16309420002 Italy 83.60.260736 iM70 260736-M16309420003 Italy 83.60.260752 iM60 VET 260752-M16313610001 United Kingdom 83.60.260752 iM60 VET 260752-M16313610002 United Kingdom 83.60.260752 iM60 VET 260752-M16313610003 United Kingdom 83.60.260752 iM60 VET 260752-M16313610004 United Kingdom 83.60.260752 iM60 VET 260752-M16313610005 United Kingdom 83.60.260753 iM70 VET 260753-M16313620001 United Kingdom 83.60.260753 iM70 VET 260753-M16313620002 United Kingdom 83.60.260753 iM70 VET 260753-M16313620003 United Kingdom 83.60.260753 iM70 VET 260753-M16313620004 United Kingdom 83.60.260753 iM70 VET 260753-M16313620005 United Kingdom 83.60.260753 iM70 VET 260753-M16313620006 United Kingdom 83.60.260753 iM70 VET 260753-M16313620007 United Kingdom 83.60.260753 iM70 VET 260753-M16313620008 United Kingdom 83.60.260793 iM60 VET 260793-M16502000001 United Kingdom 83.60.260793 iM60 VET 260793-M16502000002 United Kingdom 83.60.260793 iM60 VET 260793-M16502000003 United Kingdom 83.60.260793 iM60 VET 260793-M16502000004 United Kingdom 83.60.260793 iM60 VET 260793-M16502000005 United Kingdom 83.60.260793 iM60 VET 260793-M16502000006 United Kingdom 83.60.260793 iM60 VET 260793-M16502000007 United Kingdom 83.60.260793 iM60 VET 260793-M16502000008 United Kingdom 83.60.260793 iM60 VET 260793-M16502000009 United Kingdom 83.60.260793 iM60 VET 260793-M16502000010 United Kingdom 83.60.260793 iM60 VET 260793-M16502000011 United Kingdom 83.60.260793 iM60 VET 260793-M16502000012 United Kingdom 83.60.260793 iM60 VET 260793-M16502000013 United Kingdom 83.60.260793 iM60 VET 260793-M16502000014 United Kingdom 83.60.260793 iM60 VET 260793-M16502000015 United Kingdom 83.60.260793 iM60 VET 260793-M16502000016 United Kingdom 83.60.260793 iM60 VET 260793-M16502000017 United Kingdom 83.60.260793 iM60 VET 260793-M16502000018 United Kingdom 83.60.260793 iM60 VET 260793-M16502000019 United Kingdom 83.60.260793 iM60 VET 260793-M16502000020 United Kingdom 83.60.260793 iM60 VET 260793-M16502000021 United Kingdom 83.60.260793 iM60 VET 260793-M16502000022 United Kingdom 83.60.260793 iM60 VET 260793-M16502000023 United Kingdom 83.60.260793 iM60 VET 260793-M16502000024 United Kingdom 83.60.260793 iM60 VET 260793-M16502000025 United Kingdom 83.60.260793 iM60 VET 260793-M16507740001 United Kingdom 83.60.260793 iM60 VET 260793-M16507740002 United Kingdom 83.60.260793 iM60 VET 260793-M16507740003 United Kingdom 83.60.260793 iM60 VET 260793-M16507740004 United Kingdom 83.60.260793 iM60 VET 260793-M16507740005 United Kingdom 83.60.260793 iM60 VET 260793-M16507740006 United Kingdom 83.60.260793 iM60 VET 260793-M16507740007 United Kingdom 83.60.260793 iM60 VET 260793-M16507740008 United Kingdom 83.60.260793 iM60 VET 260793-M16507740009 United Kingdom 83.60.260793 iM60 VET 260793-M16507740010 United Kingdom 83.60.260794 iM70 VET 260794-M16507550001 United Kingdom 83.60.260794 iM70 VET 260794-M16507550002 United Kingdom 83.60.260794 iM70 VET 260794-M16507550003 United Kingdom 83.60.260794 iM70 VET 260794-M16507550004 United Kingdom 83.60.260794 iM70 VET 260794-M16507550005 United Kingdom 83.60.260814 iM60 260814-M16506890001 USA 83.60.260814 iM60 260814-M16506890002 USA 83.60.260814 iM60 260814-M16506890003 USA 83.60.260814 iM60 260814-M16506890004 USA 83.60.260814 iM60 260814-M16506890005 USA 83.60.260814 iM60 260814-M16506890006 USA 83.60.260814 iM60 260814-M16506890007 USA 83.60.260814 iM60 260814-M16506890008 USA 83.60.260814 iM60 260814-M16506890009 USA 83.60.260814 iM60 260814-M16506890010 USA 83.60.260814 iM60 260814-M16506890011 USA 83.60.260814 iM60 260814-M16506890012 USA 83.60.260814 iM60 260814-M16506890013 USA 83.60.260814 iM60 260814-M16506890014 USA 83.60.260814 iM60 260814-M16506890015 USA 83.60.260814 iM60 260814-M16509230001 USA 83.60.260814 iM60 260814-M16509230002 USA 83.60.260814 iM60 260814-M16509230003 USA 83.60.260814 iM60 260814-M16509230004 USA 83.60.260814 iM60 260814-M16509230005 USA 83.60.260814 iM60 260814-M16509230006 USA 83.60.260814 iM60 260814-M16509230007 USA 83.60.260814 iM60 260814-M16509230008 USA 83.60.260814 iM60 260814-M16509230009 USA 83.60.260814 iM60 260814-M16509230010 USA 83.60.260814 iM60 260814-M16509230011 USA 83.60.260814 iM60 260814-M16509230012 USA 83.60.260814 iM60 260814-M16509230013 USA 83.60.260814 iM60 260814-M16509230014 USA 83.60.260814 iM60 260814-M16509230015 USA 83.60.260816 iM50 260816-M16506870001 China 83.60.260816 iM50 260816-M16506870002 China 83.60.260823 iM60 260823-M16601840001 New Caledonia 83.60.260827 iM60 260827-M16602490001 India 83.60.260827 iM60 260827-M16602490002 India 83.60.344008 iM60 344008-M16404630001 Portugal 83.60.344008 iM60 344008-M16404630002 Portugal 83.60.344008 iM60 344008-M16404630003 Portugal 83.60.344008 iM60 344008-M16408540001 Portugal 83.60.344008 iM60 344008-M16408540002 Portugal 83.60.344008 iM60 344008-M16408540003 Portugal 83.60.344008 iM60 344008-M16408540004 Portugal 83.60.344009 iM60 344009-K16500160001 Lithuania 83.60.344009 iM60 344009-M16307630001 India 83.60.344009 iM60 344009-M16307630002 India 83.60.344009 iM60 344009-M16307630003 India 83.60.344009 iM60 344009-M16400760001 China 83.60.344009 iM60 344009-M16408490001 Germany 83.60.345010 iM70 345010-M16400790001 China 83.60.345010 iM70 345010-M16500940001 Argentina 83.60.345010 iM70 345010-M16500940002 Argentina 83.60.348002 V-CO2 Module 348002-M16201440003 Ethiopia 83.60.348002 V-CO2 Module 348002-M16201440005 Ethiopia 83.60.348002 V-CO2 Module 348002-M16204980001 India 83.60.348002 V-CO2 Module 348002-M16309110001 Italy 83.60.348002 V-CO2 Module 348002-M16311480001 Macedonia 83.60.348002 V-CO2 Module 348002-M16311710001 Macedonia 83.60.348002 V-CO2 Module 348002-M16311710002 Macedonia 83.60.348002 V-CO2 Module 348002-M16311710003 India 83.60.348002 V-CO2 Module 348002-M16311710004 India 83.60.348002 V-CO2 Module 348002-M16311710005 India 83.60.348002 V-CO2 Module 348002-M16311710006 India 83.60.348002 V-CO2 Module 348002-M16313650001 India 83.60.348002 V-CO2 Module 348002-M16313910001 Malaysia 83.60.348002 V-CO2 Module 348002-M16313910002 Malaysia 83.60.348002 V-CO2 Module 348002-M16313910003 Malaysia 83.60.348002 V-CO2 Module 348002-M16400580001 India 83.60.348002 V-CO2 Module 348002-M16400580002 Macedonia 83.60.348002 V-CO2 Module 348002-M16400580003 India 83.60.360147 iM8 360147-M16304980001 France 83.60.360245 iM70 360245-M16400780001 India |
Recalling Firm/
Manufacturer |
Edan Diagnostics
9833 Pacific Heights Blvd
San Diego CA 92121-4707
|
| For Additional Information Contact |
Doug Worth
650-438-3051
|
Manufacturer Reason
for Recall |
Incorrect CO2 readings with some patient monitors.
|
FDA Determined
Cause 2 |
Nonconforming Material/Component |
| Action |
The firm, EDAN, sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated 6/23/2016 via email to its customers on 06/23/16. The letter described the product, problem and actions to be taken.
Customers were provided two possible solutions.
1. Re-calibrate the affected monitors:
a. The customer needs to source the Calibration Gas and other tools locally, EDAN will provide the Specifications of the Calibration Gas;
b. EDAN will provide Calibration Instructions to the customer;
c. The customer need to calibrate the monitors by themselves and send the Calibration Record back to EDAN.
2. Replace the EtCO2 modules on the affected monitors:
a. EDAN will provide new, correctly calibrated, EtCO2 modules with replacement instructions free of charge;
b. The customer shall replace the modules by themselves and send the Replacement Record back to EDAN;
c. The customer shall send the faulty EtCO2 modules back to EDAN.
For customers who received affected EtCO2 modules as spare parts:
1. The customer can return the affected modules back to EDAN and ask for a refund or credit, or have these modules replaced with new ones.
2. If any of the affected module has been used on a monitor, the customer should replace the module used with new one.
3. The customer shall send the affected EtCO2 modules back to EDAN.
Any questions contact EDAN service engineer who responsible for your country/region or at phone numbers listed below:
EDAN Instruments, Inc.
Monday to Friday 09:00-17:00 (UTC +08:00) Tel: +86-755-26812296
EDAN Instruments GmbH
Monday to Friday 09:00-17:00 (UTC +01:00) Tel: +49 (0) 6103 202 0781
EDAN Diagnostics, Inc.
Monday to Friday 09:00-17:00 (UTC -08:00) Tel: +1 858 750 3066 |
| Quantity in Commerce |
521 |
| Distribution |
Worldwide Distribution-U.S (nationwide) distribution to the following states; FL, KY, CA; and countries of: Argentina, China, Colombia, , Ethiopia, France, Germany, Guatemala, India, Italy, Lao People's Democratic Republic, Lithuania, Malaysia, Macedonia, Nepal, New Caledonia, Nicaragua, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Sudan, Senegal, Sri Lanka, Thailand, Turkey, United Kingdom, and Uruguay. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = MHX and Original Applicant = EDAN INSTRUMENTS, INC.
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