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Class 1 Device Recall CARESCAPE Respiratory Module EsCAiO |
 |
| Date Initiated by Firm |
September 27, 2019 |
| Date Posted |
January 10, 2020 |
| Recall Status1 |
Terminated 3 on September 26, 2023 |
| Recall Number |
Z-0756-2020 |
| Recall Event ID |
84034 |
| 510(K)Number |
K183394 K171028 K150245 K123195
|
| Product Classification |
Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
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| Product |
CARESCAPE Respiratory Module E-sCAiO |
| Code Information |
Mfg. Lot or Serial # UDI # SGV19240073HA 010084068210418021SGV19240073HA11190611 SGV19280017HA 010084068210418021SGV19280017HA11190708 SGV18150053HA 010084068210418021SGV18150053HA11180411 SGV19240172HA 010084068210418021SGV19240172HA11190612 SGV19240084HA 010084068210418021SGV19240084HA11190611 SGV19240085HA 010084068210418021SGV19240085HA11190611 SGV19240076HA 010084068210418021SGV19240076HA11190611 SGV19240142HA 010084068210418021SGV19240142HA11190612 SGV19280114HA 010084068210418021SGV19280114HA11190709 SGV19280029HA 010084068210418021SGV19280029HA11190708 SGV19240095HA 010084068210418021SGV19240095HA11190611 SGV19270021HA 010084068210418021SGV19270021HA11190702 SGV19240272HA 010084068210418021SGV19240272HA11190613 SGV19270085HA 010084068210418021SGV19270085HA11190704 SGV19260064HA 010084068210418021SGV19260064HA11190628 SGV19240108HA 010084068210418021SGV19240108HA11190611 SGV19240104HA 010084068210418021SGV19240104HA11190611 SGV19240129HA 010084068210418021SGV19240129HA11190612 SGV19240103HA 010084068210418021SGV19240103HA11190611 SGV19240109HA 010084068210418021SGV19240109HA11190611 SGV19250088HA 010084068210418021SGV19250088HA11190617 SGV19250157HA 010084068210418021SGV19250157HA11190620 SGV19250049HA 010084068210418021SGV19250049HA11190617 SGV19240060HA 010084068210418021SGV19240060HA11190611 SGV19240268HA 010084068210418021SGV19240268HA11190613 SGV19250003HA 010084068210418021SGV19250003HA11190617 SGV19250061HA 010084068210418021SGV19250061HA11190617 SGV19250093HA 010084068210418021SGV19250093HA11190617 SGV19250110HA 010084068210418021SGV19250110HA11190620 SGV19250125HA 010084068210418021SGV19250125HA11190620 SGV19260066HA 010084068210418021SGV19260066HA11190628 SGV19260091HA 010084068210418021SGV19260091HA11190628 SGV19250132HA 010084068210418021SGV19250132HA11190620 SGV19260071HA 010084068210418021SGV19260071HA11190628 SGV19250114HA 010084068210418021SGV19250114HA11190620 SGV19290096HA 010084068210418021SGV19290096HA11190716 SGV19250102HA 010084068210418021SGV19250102HA11190620 SGV19280088HA 010084068210418021SGV19280088HA11190708 SGV19270089HA 010084068210418021SGV19270089HA11190704 SGV19240195HA 010084068210418021SGV19240195HA11190612 SGV19260093HA 010084068210418021SGV19260093HA11190628 SGV19300001HA 010084068210418021SGV19300001HA11190723 SGV19280113HA 010084068210418021SGV19280113HA11190709 SGV19240185HA 010084068210418021SGV19240185HA11190612 SGV19270127HA 010084068210418021SGV19270127HA11190705 SGV19250067HA 010084068210418021SGV19250067HA11190617 SGV19270084HA 010084068210418021SGV19270084HA11190704 SGV19280163HA 010084068210418021SGV19280163HA11190709 SGV19280083HA 010084068210418021SGV19280083HA11190708 SGV19270011HA 010084068210418021SGV19270011HA11190702 SGV19260047HA 010084068210418021SGV19260047HA11190628 SGV19280087HA 010084068210418021SGV19280087HA11190708 SGV19240101HA 010084068210418021SGV19240101HA11190611 SGV19240094HA 010084068210418021SGV19240094HA11190611 SGV19240114HA 010084068210418021SGV19240114HA11190611 SGV19240132HA 010084068210418021SGV19240132HA11190612 SGV19240159HA 010084068210418021SGV19240159HA11190612 SGV19240180HA 010084068210418021SGV19240180HA11190612 SGV19240181HA 010084068210418021SGV19240181HA11190612 SGV19240112HA 010084068210418021SGV19240112HA11190611 SGV19240150HA 010084068210418021SGV19240150HA11190612 SGV19240179HA 010084068210418021SGV19240179HA11190612 SGV19240183HA 010084068210418021SGV19240183HA11190612 SGV19240196HA 010084068210418021SGV19240196HA11190612 SGV19240204HA 010084068210418021SGV19240204HA11190612 SGV19240211HA 010084068210418021SGV19240211HA11190612 SGV19270040HA 010084068210418021SGV19270040HA11190702 SGV19280005HA 010084068210418021SGV19280005HA11190708 SGV19280010HA 010084068210418021SGV19280010HA11190708 SGV19240276HA 010084068210418021SGV19240276HA11190613 SGV19270064HA 010084068210418021SGV19270064HA11190704 SGV19270082HA 010084068210418021SGV19270082HA11190704 SGV19270111HA 010084068210418021SGV19270111HA11190705 SGV19280166HA 010084068210418021SGV19280166HA11190709 SGV19260075HA 010084068210418021SGV19260075HA11190628 SGV19260087HA 010084068210418021SGV19260087HA11190628 SGV19260089HA 010084068210418021SGV19260089HA11190628 SGV19250089HA 010084068210418021SGV19250089HA11190617 SGV19240090HA 010084068210418021SGV19240090HA11190611 SGV19240091HA 010084068210418021SGV19240091HA11190611 SGV19240156HA 010084068210418021SGV19240156HA11190612 SGV19240158HA 010084068210418021SGV19240158HA11190612 SGV19240168HA 010084068210418021SGV19240168HA11190612 SGV19240269HA 010084068210418021SGV19240269HA11190613 SGV19240366HA 010084068210418021SGV19240366HA11190613 SGV19240371HA 010084068210418021SGV19240371HA11190613 SGV19240413HA 010084068210418021SGV19240413HA11190613 SGV19250005HA 010084068210418021SGV19250005HA11190617 SGV19250006HA 010084068210418021SGV19250006HA11190617 SGV19250007HA 010084068210418021SGV19250007HA11190617 SGV19250023HA 010084068210418021SGV19250023HA11190617 SGV19250034HA 010084068210418021SGV19250034HA11190617 SGV19250035HA 010084068210418021SGV19250035HA11190617 SGV19250037HA 010084068210418021SGV19250037HA11190617 SGV19250062HA 010084068210418021SGV19250062HA11190617 SGV19250065HA 010084068210418021SGV19250065HA11190617 SGV19250068HA 010084068210418021SGV19250068HA11190617 SGV19250069HA 010084068210418021SGV19250069HA11190617 SGV19250076HA 010084068210418021SGV19250076HA11190617 SGV19250080HA 010084068210418021SGV19250080HA11190617 SGV19250083HA 010084068210418021SGV19250083HA11190617 SGV19250094HA 010084068210418021SGV19250094HA11190617 SGV19250095HA 010084068210418021SGV19250095HA11190617 SGV19250107HA 010084068210418021SGV19250107HA11190620 SGV19250131HA 010084068210418021SGV19250131HA11190620 SGV19250139HA 010084068210418021SGV19250139HA11190620 SGV19260074HA 010084068210418021SGV19260074HA11190628 SGV19260084HA 010084068210418021SGV19260084HA11190628 SGV19250120HA 010084068210418021SGV19250120HA11190620 SGV19290101HA 010084068210418021SGV19290101HA11190716 SGV19290111HA 010084068210418021SGV19290111HA11190716 SGV19290125HA 010084068210418021SGV19290125HA11190718 SGV19290157HA 010084068210418021SGV19290157HA11190718 SGV19260055HA 010084068210418021SGV19260055HA11190628 SGV19260065HA 010084068210418021SGV19260065HA11190628 SGV19260077HA 010084068210418021SGV19260077HA11190628 SGV19270045HA 010084068210418021SGV19270045HA11190702 SGV19300040HA 010084068210418021SGV19300040HA11190723 SGV19300042HA 010084068210418021SGV19300042HA11190723 SGV19280094HA 010084068210418021SGV19280094HA11190709 SGV19290061HA 010084068210418021SGV19290061HA11190715 SGV19290063HA 010084068210418021SGV19290063HA11190715 SGV19250156HA 010084068210418021SGV19250156HA11190620 SGV19280106HA 010084068210418021SGV19280106HA11190709 SGV19280179HA 010084068210418021SGV19280179HA11190709 SGV19280152HA 010084068210418021SGV19280152HA11190709 SGV19280153HA 010084068210418021SGV19280153HA11190709 SGV19280157HA 010084068210418021SGV19280157HA11190709 SGV19260049HA 010084068210418021SGV19260049HA11190628 SGV19260052HA 010084068210418021SGV19260052HA11190628 SGV19260088HA 010084068210418021SGV19260088HA11190628 SGV19270004HA 010084068210418021SGV19270004HA11190702 SGV19270006HA 010084068210418021SGV19270006HA11190702 SGV19270029HA 010084068210418021SGV19270029HA11190702 SGV19270032HA 010084068210418021SGV19270032HA11190702 SGV19270042HA 010084068210418021SGV19270042HA11190702 SGV19270044HA 010084068210418021SGV19270044HA11190702 SGV19270058HA 010084068210418021SGV19270058HA11190704 SGV19270059HA 010084068210418021SGV19270059HA11190704 SGV19270061HA 010084068210418021SGV19270061HA11190704 SGV19270066HA 010084068210418021SGV19270066HA11190704 SGV19270067HA 010084068210418021SGV19270067HA11190704 SGV19270069HA 010084068210418021SGV19270069HA11190704 SGV19270072HA 010084068210418021SGV19270072HA11190704 SGV19270077HA 010084068210418021SGV19270077HA11190704 SGV19270078HA 010084068210418021SGV19270078HA11190704 SGV19280110HA 010084068210418021SGV19280110HA11190709 SGV19280111HA 010084068210418021SGV19280111HA11190709 SGV19280127HA 010084068210418021SGV19280127HA11190709 SGV19280128HA 010084068210418021SGV19280128HA11190709 SGV19280131HA 010084068210418021SGV19280131HA11190709 SGV19280138HA 010084068210418021SGV19280138HA11190709 SGV19280165HA 010084068210418021SGV19280165HA11190709 SGV19280167HA 010084068210418021SGV19280167HA11190709 SGV15101460HA Not Applicable SGV17350070HA Not Applicable SGV19269301HA Not Applicable SGV19269306HA Not Applicable SGV19269309HA Not Applicable SGV17060103HA Not Applicable SGV18300094HA Not Applicable |
Recalling Firm/
Manufacturer |
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
|
| For Additional Information Contact |
GE Healthcare Service
800-437-1171
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Manufacturer Reason
for Recall |
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
|
FDA Determined
Cause 2 |
Process control |
| Action |
The firm issued the Urgent Medical Device Correction Letter dated 09/27/2019. The letter describes the failure and requests replacement of the affected module with another module. If a replacement is not available, the consignee is directed to follow the instructions below to ensure that your respiratory module O2 reading is within specifications (a) before any new patient case is started and (b) for prolonged patient cases, at a minimum of once a day:
1) Connect the module to the host device;
2) Ensure the module is fully warmed up by having it powered on for minimum 20 minutes;
3) Configure the O2 reading and waveform to the host device screen as defined in the host device instructions;
4) Feed 100% O2 gas flow from the ventilator to the module and observe the O2 reading and waveform; and
5) Ensure the O2 reading is within specifications 100% +/-3% and there is no erratic behavior in the waveform.
6) If you are unable to complete the above steps successfully, remove the respiratory module from clinical use and quarantine.
Contact GE Healthcare Service or your local Service Representative.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity in Commerce |
161 units |
| Distribution |
US
OUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom |
| Total Product Life Cycle |
TPLC Device Report
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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.
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| 510(K) Database |
510(K)s with Product Code = CCK and Original Applicant = GE HEALTHCARE FINLAND OY
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