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U.S. Department of Health and Human Services

Class 1 Device Recall CARESCAPE Respiratory Module EsCO

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  Class 1 Device Recall CARESCAPE Respiratory Module EsCO see related information
Date Initiated by Firm September 27, 2019
Date Posted January 10, 2020
Recall Status1 Terminated 3 on September 26, 2023
Recall Number Z-0754-2020
Recall Event ID 84034
510(K)Number K183394  K171028  K150245  K123195  
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product CARESCAPE Respiratory Module E-sCO
Code Information Mfg. Lot or Serial # UDI # SGV19241006HA 010084068210417321SGV19241006HA11190614 SGV19241003HA 010084068210417321SGV19241003HA11190614 SGV19241044HA 010084068210417321SGV19241044HA11190614 SGV19241053HA 010084068210417321SGV19241053HA11190614 SGV19241033HA 010084068210417321SGV19241033HA11190614 SGV19241036HA 010084068210417321SGV19241036HA11190614 SGV19241010HA 010084068210417321SGV19241010HA11190614 SGV19251068HA 010084068210417321SGV19251068HA11190619 SGV19251002HA 010084068210417321SGV19251002HA11190619 SGV19251033HA 010084068210417321SGV19251033HA11190619 SGV19241026HA 010084068210417321SGV19241026HA11190614 SGV19241014HA 010084068210417321SGV19241014HA11190614 SGV19261077HA 010084068210417321SGV19261077HA11190624 SGV19241055HA 010084068210417321SGV19241055HA11190614 SGV19241001HA 010084068210417321SGV19241001HA11190614 SGV19251052HA 010084068210417321SGV19251052HA11190619 SGV19241025HA 010084068210417321SGV19241025HA11190614 SGV19241002HA 010084068210417321SGV19241002HA11190614 SGV19261007HA 010084068210417321SGV19261007HA11190624 SGV19241023HA 010084068210417321SGV19241023HA11190614 SGV19251116HA 010084068210417321SGV19251116HA11190619 SGV19241060HA 010084068210417321SGV19241060HA11190614 SGV19241043HA 010084068210417321SGV19241043HA11190614 SGV19251037HA 010084068210417321SGV19251037HA11190619 SGV19261009HA 010084068210417321SGV19261009HA11190624 SGV19251092HA 010084068210417321SGV19251092HA11190619 SGV19281055HA 010084068210417321SGV19281055HA11190711 SGV19261023HA 010084068210417321SGV19261023HA11190624 SGV19261144HA 010084068210417321SGV19261144HA11190625 SGV19251023HA 010084068210417321SGV19251023HA11190619 SGV19251098HA 010084068210417321SGV19251098HA11190619 SGV19241035HA 010084068210417321SGV19241035HA11190614 SGV19241007HA 010084068210417321SGV19241007HA11190614 SGV19241017HA 010084068210417321SGV19241017HA11190614 SGV19241041HA 010084068210417321SGV19241041HA11190614 SGV19251007HA 010084068210417321SGV19251007HA11190619 SGV19251079HA 010084068210417321SGV19251079HA11190619 SGV19261034HA 010084068210417321SGV19261034HA11190624 SGV19261184HA 010084068210417321SGV19261184HA11190627 SGV19271150HA 010084068210417321SGV19271150HA11190704 SGV19271152HA 010084068210417321SGV19271152HA11190704 SGV19271170HA 010084068210417321SGV19271170HA11190704 SGV19271175HA 010084068210417321SGV19271175HA11190704 SGV19241011HA 010084068210417321SGV19241011HA11190614 SGV19241024HA 010084068210417321SGV19241024HA11190614 SGV19251081HA 010084068210417321SGV19251081HA11190619 SGV19251111HA 010084068210417321SGV19251111HA11190619 SGV19261091HA 010084068210417321SGV19261091HA11190624 SGV19261096HA 010084068210417321SGV19261096HA11190625 SGV19271157HA 010084068210417321SGV19271157HA11190704 SGV19241049HA 010084068210417321SGV19241049HA11190614 SGV19261114HA 010084068210417321SGV19261114HA11190625 SGV19261122HA 010084068210417321SGV19261122HA11190625 SGV19251045HA 010084068210417321SGV19251045HA11190619 SGV19251051HA 010084068210417321SGV19251051HA11190619 SGV19251062HA 010084068210417321SGV19251062HA11190619 SGV19251071HA 010084068210417321SGV19251071HA11190619 SGV19261017HA 010084068210417321SGV19261017HA11190624 SGV19261032HA 010084068210417321SGV19261032HA11190624 SGV19261089HA 010084068210417321SGV19261089HA11190624 SGV19261111HA 010084068210417321SGV19261111HA11190625 SGV19261117HA 010084068210417321SGV19261117HA11190625 SGV19261128HA 010084068210417321SGV19261128HA11190625 SGV19271112HA 010084068210417321SGV19271112HA11190703 SGV19271136HA 010084068210417321SGV19271136HA11190704 SGV19251034HA 010084068210417321SGV19251034HA11190619 SGV19251049HA 010084068210417321SGV19251049HA11190619 SGV19251059HA 010084068210417321SGV19251059HA11190619 SGV19261097HA 010084068210417321SGV19261097HA11190625 SGV19271137HA 010084068210417321SGV19271137HA11190704 SGV19271177HA 010084068210417321SGV19271177HA11190704 SGV19261098HA 010084068210417321SGV19261098HA11190625 SGV19261005HA 010084068210417321SGV19261005HA11190624 SGV19241038HA 010084068210417321SGV19241038HA11190614 SGV19241040HA 010084068210417321SGV19241040HA11190614 SGV19241042HA 010084068210417321SGV19241042HA11190614 SGV19241048HA 010084068210417321SGV19241048HA11190614 SGV19241056HA 010084068210417321SGV19241056HA11190614 SGV19241059HA 010084068210417321SGV19241059HA11190614 SGV19251057HA 010084068210417321SGV19251057HA11190619 SGV19251060HA 010084068210417321SGV19251060HA11190619 SGV19251067HA 010084068210417321SGV19251067HA11190619 SGV19251091HA 010084068210417321SGV19251091HA11190619 SGV19251099HA 010084068210417321SGV19251099HA11190619 SGV19251110HA 010084068210417321SGV19251110HA11190619 SGV19261021HA 010084068210417321SGV19261021HA11190624 SGV19261027HA 010084068210417321SGV19261027HA11190624 SGV19261087HA 010084068210417321SGV19261087HA11190624 SGV19261088HA 010084068210417321SGV19261088HA11190624 SGV19261106HA 010084068210417321SGV19261106HA11190625 SGV19261108HA 010084068210417321SGV19261108HA11190625 SGV19261119HA 010084068210417321SGV19261119HA11190625 SGV19261121HA 010084068210417321SGV19261121HA11190625 SGV19261127HA 010084068210417321SGV19261127HA11190625 SGV19261133HA 010084068210417321SGV19261133HA11190625 SGV19261139HA 010084068210417321SGV19261139HA11190625 SGV19261141HA 010084068210417321SGV19261141HA11190625 SGV19261143HA 010084068210417321SGV19261143HA11190625 SGV19261166HA 010084068210417321SGV19261166HA11190625 SGV19261168HA 010084068210417321SGV19261168HA11190625 SGV19261170HA 010084068210417321SGV19261170HA11190625 SGV19261191HA 010084068210417321SGV19261191HA11190627 SGV19261193HA 010084068210417321SGV19261193HA11190627 SGV19261196HA 010084068210417321SGV19261196HA11190627 SGV19261197HA 010084068210417321SGV19261197HA11190627 SGV19261199HA 010084068210417321SGV19261199HA11190627 SGV19271015HA 010084068210417321SGV19271015HA11190701 SGV19271021HA 010084068210417321SGV19271021HA11190701 SGV19271022HA 010084068210417321SGV19271022HA11190701 SGV19271039HA 010084068210417321SGV19271039HA11190701 SGV19271042HA 010084068210417321SGV19271042HA11190701 SGV19271043HA 010084068210417321SGV19271043HA11190701 SGV19271050HA 010084068210417321SGV19271050HA11190701 SGV19271064HA 010084068210417321SGV19271064HA11190701 SGV19241047HA 010084068210417321SGV19241047HA11190614 SGV19251055HA 010084068210417321SGV19251055HA11190619 SGV19251064HA 010084068210417321SGV19251064HA11190619 SGV19251082HA 010084068210417321SGV19251082HA11190619 SGV19251109HA 010084068210417321SGV19251109HA11190619 SGV19251117HA 010084068210417321SGV19251117HA11190619 SGV19241051HA 010084068210417321SGV19241051HA11190614 SGV19251044HA 010084068210417321SGV19251044HA11190619 SGV19251058HA 010084068210417321SGV19251058HA11190619 SGV19251102HA 010084068210417321SGV19251102HA11190619 SGV19251113HA 010084068210417321SGV19251113HA11190619 SGV19261094HA 010084068210417321SGV19261094HA11190625 SGV19261142HA 010084068210417321SGV19261142HA11190625 SGV19251106HA 010084068210417321SGV19251106HA11190619 SGV19261099HA 010084068210417321SGV19261099HA11190625 SGV19241005HA 010084068210417321SGV19241005HA11190614 SGV19251020HA 010084068210417321SGV19251020HA11190619 SGV19251084HA 010084068210417321SGV19251084HA11190619 SGV19251112HA 010084068210417321SGV19251112HA11190619 SGV19261016HA 010084068210417321SGV19261016HA11190624 SGV19261033HA 010084068210417321SGV19261033HA11190624 SGV19261084HA 010084068210417321SGV19261084HA11190624 SGV19261090HA 010084068210417321SGV19261090HA11190624 SGV19261100HA 010084068210417321SGV19261100HA11190625 SGV19261110HA 010084068210417321SGV19261110HA11190625 SGV19261086HA 010084068210417321SGV19261086HA11190624 SGV19271041HA 010084068210417321SGV19271041HA11190701 SGV19241034HA 010084068210417321SGV19241034HA11190614 SGV19261010HA 010084068210417321SGV19261010HA11190624 SGV19261028HA 010084068210417321SGV19261028HA11190624 SGV19251019HA 010084068210417321SGV19251019HA11190619 SGV19251024HA 010084068210417321SGV19251024HA11190619 SGV19251114HA 010084068210417321SGV19251114HA11190619 SGV19271047HA 010084068210417321SGV19271047HA11190701 SGV19261006HA 010084068210417321SGV19261006HA11190624 SGV19261165HA 010084068210417321SGV19261165HA11190625 SGV19271099HA 010084068210417321SGV19271099HA11190703 SGV19261203HA 010084068210417321SGV19261203HA11190627 SGV19271028HA 010084068210417321SGV19271028HA11190701 SGV19271052HA 010084068210417321SGV19271052HA11190701 SGV19271162HA 010084068210417321SGV19271162HA11190704 SGV19281056HA 010084068210417321SGV19281056HA11190711 SGV19281060HA 010084068210417321SGV19281060HA11190711 SGV19261030HA 010084068210417321SGV19261030HA11190624 SGV19261149HA 010084068210417321SGV19261149HA11190625 SGV19261152HA 010084068210417321SGV19261152HA11190625 SGV19261146HA 010084068210417321SGV19261146HA11190625 SGV19261151HA 010084068210417321SGV19261151HA11190625 SGV19261031HA 010084068210417321SGV19261031HA11190624 SGV19261015HA 010084068210417321SGV19261015HA11190624 SGV19261024HA 010084068210417321SGV19261024HA11190624 SGV19261025HA 010084068210417321SGV19261025HA11190624 SGV14052384HA 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
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 167 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
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 = CCK and Original Applicant = GE HEALTHCARE FINLAND OY
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