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U.S. Department of Health and Human Services

Class 1 Device Recall Philips Trilogy 200 Ventilator

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  Class 1 Device Recall Philips Trilogy 200 Ventilator see related information
Date Initiated by Firm December 07, 2022
Date Posted January 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-0883-2023
Recall Event ID 91293
510(K)Number K093416  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
Code Information UDI: 00606959429154 00606959429208 00606959429147 00606959429185 00606959429710 00606959429611 00606959429475 00606959429260 00606959033986 00606959033993 00606959429444; Serial Numbers: TV212103056 TV213062024 TV214101606 TV210092113 TV211113009 TV212022810 TV212062641 TV214031911 TV214040418 TV214040414 TV21404041D TV214041501 TV21404041C TV214061728 TV21406171F TV21412160E TV215030665 TV215100123 TV21706280E TV217092201 TV217122107 TV217122113 TV219090909 TV21909091B TV210081103 TV210082301 TV210092106 TV210102509 TV211051303 TV211080213 TV211092124 TV212051425 TV212062657 TV213042329 TV213050906 TV21402100B TV21403186A TV214040816 TV214060402 TV214100114 TV214100115 TV214102009 TV214102008 TV21507270A TV215100201 TV21608016D TV21608037C TV21608037B TV217120409 TV219090913 TV212062268 TV213121266 TV220111614 TV220112315 TV212062243 TV214081917 TV210072214 TV210072245 TV211060304 TV211060124 TV211060320 TV211060309 TV211092126 TV212020645 TV213012231 TV213042341 TV213092015 TV213102323 TV21401211B TV21401240B TV214021019 TV21402111E TV21403110F TV214030515 TV21403186E TV214052307 TV214060408 TV214070902 TV214072266 TV214081914 TV21408191E TV214100118 TV214101604 TV215010902 TV215040915 TV215051102 TV215061205 TV215061203 TV21506050A TV215072908 TV215082701 TV215082711 TV215091401 TV215092414 TV215093006 TV215100817 TV215100820 TV21510081E TV21511061D TV216021114 TV216021116 TV216021119 TV216021727 TV216021730 TV216031713 TV21603171B TV216031503 TV21603171C TV216040153 TV216041217 TV21604121E TV216062160 TV216110309 TV21612070B TV217062804 TV217062701 TV217062704 TV217062703 TV217062808 TV217062811 TV217090516 TV217112716 TV21711271A TV218020803 TV218021509 TV21802150C TV218021508 TV21802150E TV21806123A TV21806123F TV21806122E TV218061220 TV2180627B7 TV219041213 TV21904290E TV21906050D TV219101502 TV219101505 TV219101501 TV219111301 TV21912185D TV210110321 TV212041013 TV212051047 TV212062565 TV212062563 TV212103051 TV213012215 TV213022078 TV213081307 TV213082813 TV213092019 TV21312170E TV214031009 TV21404266C TV21408221E TV214112003 TV21412153E TV21502191F TV216060906 TV216060909 TV217090118 TV219111305 TV215062211 TV215062909 TV216120708 TV217122104 TV21712210E TV218050852 TV213011751 TV218020209 TV212031340 TV21405230A TV214012412 TV214081204 TV214081506 TV214081508 TV21409080B TV214100715 TV214121220 TV21509140F TV215100210 TV21704251D TV21903063D TV219112111 TV219120903 TV218102928 TV218102916 TV218090751 TV21806261D TV218062670 TV217100413 TV21701163E TV217011806 TV218090758 TV219120904 TV217100444 TV218090732 TV21810307D TV217011640 TV219111801 TV218112902 TV21811290E TV218113001 TV218112821 TV218061434 TV219100819 TV218112938 TV21811290A TV218112909 TV218062646 TV219100810 TV219100808 TV218113005 TV21811271F TV218112647 TV21811290F TV218062627 TV219111805 TV219100816 TV218112632 TV21811262D TV218062611 TV218113029 TV21808104B TV219111809 TV21806260E TV218112925 TV218062608 TV218062637 TV21806266A TV21806266B TV218112648 TV218112810 TV21811292E TV218113002 TV218113018 TV21705230B TV217053015 TV21705301A TV218011805 TV218011806 TV218011807 TV218011808 TV21801180B TV21801180C TV218011810 TV218060818 TV218060819 TV218060825 TV218061436 TV21806263F TV218062675 TV218081029 TV21808102A TV218081030 TV21808103E TV21808103F TV218081040 TV21808104C TV218112624 TV218112633 TV21811263E TV21811273E TV217052208 TV218011801 TV218011811 TV218011814 TV21912060C TV218031402 TV217011804 TV217052203 TV217011805 TV217011807 TV217111519 TV21705261B TV21810307E TV218062644 TV217111518 TV217052204 TV219120909 TV21710044C TV217011638 TV217052305 TV21912060A TV21810290F TV21711151C TV218061435 TV217071915 TV21711161B TV218062625 TV218020720 TV21802071F TV218062669 TV21705220A TV217011632 TV218113011 TV217111615 TV219120607 TV217111517 TV21701180C TV21912060E TV218031405 TV219120608 TV218062657 TV21810306F TV21806260F TV21701180E TV21811273B TV219100801 TV21811302B TV21806265B TV217011705 TV21710044A TV218081047 TV21806267D TV218062622 TV21701180A TV217052209 TV21810307C TV21711151A Tv21912060B TV21912090C TV21705220B TV218011803 TV218011804 TV218011809 TV21801180D TV218011812 TV218011813 TV21806080D TV21806080F TV218060824 TV218081048 TV218112701 TV21811281D Tv217052211 TV21705230E TV217071916 TV217011802 TV219120605 TV219050208 TV218031407 TV213111407 TV215112002 TV21604282C TV216052707 TV216062201 TV216062202 TV21608291A TV2160830F5 TV216100406 TV216110122 TV216120602 TV217010304 TV217010306 TV217013106 TV217013108 TV217021303 TV217021307 TV217033102 TV217060616 TV21708171B TV217100518 TV21710051A TV21710051C TV21711090B TV21711090F TV217110910 TV21801181A TV218011820 TV218011821 TV218011822 TV218011824 TV21801182C TV218011830 TV218011832 TV218020623 TV218020714 TV218020715 TV218020719 TV21802071C TV218030618 TV21803300F TV21810010D TV218112108 TV219010302 TV219010316 TV21901032F TV219010333 TV21901033A TV21902121D TV21311271B TV214060207 TV214060214 TV21511200A TV216022456 TV216022459 TV21602245C TV21602245D TV216032501 TV216032503 TV216032504 TV216041321 TV216041322 TV216042828 TV216042829 TV21604282E TV216042830 TV216042832 TV21604283D TV216042841 TV216042842 TV216052706 TV21605270A TV21605270C TV21606220F TV21607204C TV216072050 TV216072051 TV216072052 TV21607295B TV21607295C TV21608037A TV216081145 TV21608290F TV216082911 TV216082912 TV2160830EB TV2160830F4 TV216100405 TV216100408 TV216100409 TV21610040D TV21610040E TV21611012C TV216110131 TV216120601 TV21612060B TV217010301 TV217010302 TV217010305 TV217013101 TV217013102 TV217013104 TV217021301 TV217021302 TV217021304 TV217031086 TV217040703 TV21705110A TV21705110C TV217051112 TV217051202 TV217051206 TV217051207 TV21705120A TV21705120D TV21705120E TV21705120F TV217051210 TV217051211 TV217051212 TV217051213 TV217051215 TV217051216 TV217060614 TV217060617 TV217071001 TV217071002 TV217071003 TV217071005 TV217071007 TV21707100A TV21708171C TV217100514 TV217100516 TV21710051B TV217100525 TV217100526 TV21710052C TV21710060C TV217110903 TV217110905 TV21711090C TV21711090D TV217110914 TV218011815 TV21801181E TV21801182A TV21801182D TV218011836 TV218011837 TV21802061C TV21802061F TV218020624 TV218020713 TV218020717 TV218030615 TV218030616 TV218030619 TV21803061A TV21803061B TV21803061C TV218033001 TV218033003 TV218033005 TV21803300A TV21803300D TV218033011 TV218100116 TV218100130 TV218100136 TV218100138 TV21811210B TV21901030D TV21901030E TV219010322 TV21901032B TV21901032E TV219010332 TV21902120C TV21902120D TV21902120E TV219021219 TV21902121A TV21902121F TV219021344 TV21902134F TV219021350 TV21903144D TV219041101 TV219041104 TV219050310 TV219070902 TV219070903 TV212062653 TV212041012
Recalling Firm/
Manufacturer		 Philips Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
For Additional Information Contact Philips Customer Service
800-345-6443
Manufacturer Reason
for Recall		 The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
FDA Determined
Cause 2		 Process design
Action Telephone calls and URGENT Medical Device Recall notification letters were distributed beginning 12/6/22. Actions you must take as a device owner or healthcare provider to prevent risks for patients. Device is on patients: For affected Trilogy 100 and Trilogy 200 devices that are on patients, ensure that your clinical assessment of the patients is up to date, reflecting the true acuity of the patients and their respiratory therapy requirements. Your patient may experience serious harm if their device malfunctions and immediate intervention is not available. Until Philips Respironics is able to correct this problem you must adhere to the instructions below. Further instructions are provided below for devices that are not on patients. ¿ For ventilator dependent patients: 1. Consider transitioning ventilator dependent patients to an alternative life-support ventilator if, as determined by the clinical assessment for the individual patient in consultation with the patient s healthcare provider, a malfunction would lead to serious injury if timely access to a backup ventilator is not possible. 2. Quarantine all impacted devices that are removed from service. 3. Please indicate which Serial Numbers must be removed from service in exchange for an alternative device For all other patients: 1. Ensure that device alarm settings are configured appropriately for your patient s needs, with special consideration for the alarms listed below. Ensure that alternative ventilation equipment is available, as appropriate to patient need, in case of emergency issues with alarms that cannot be resolved. 2. Ensure that backup monitoring is configured as required by the clinical assessment. Pulse oximetry, ECG, heart rate, blood pressure, or respiratory rate may provide additional advanced warning of and lead to faster intervention if hypoxemia were to occur. If these accessories are prescribed, ensure patients advised of proper use. 3. Consider using an inline bacterial filter which ma
Quantity in Commerce 537 devices
Distribution US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS, INC.
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