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U.S. Department of Health and Human Services

Class 1 Device Recall CARESCAPE Respiratory Module EsCAiOE

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  Class 1 Device Recall CARESCAPE Respiratory Module EsCAiOE 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-0758-2020
Recall Event ID 84034
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product CARESCAPE Respiratory Module E-sCAiOE
Code Information Mfg. Lot or Serial # UDI # SGV19254028HA 010084068210413521SGV19254028HA11190618 SGV19274009HA 010084068210413521SGV19274009HA11190703 SGV19264036HA 010084068210413521SGV19264036HA11190626 SGV19264004HA 010084068210413521SGV19264004HA11190626 SGV19264026HA 010084068210413521SGV19264026HA11190626 SGV19254040HA 010084068210413521SGV19254040HA11190618 SGV19264011HA 010084068210413521SGV19264011HA11190626 SGV19264051HA 010084068210413521SGV19264051HA11190626 SGV19264008HA 010084068210413521SGV19264008HA11190626 SGV19254034HA 010084068210413521SGV19254034HA11190618 SGV19264012HA 010084068210413521SGV19264012HA11190626 SGV19254025HA 010084068210413521SGV19254025HA11190618 SGV19274035HA 010084068210413521SGV19274035HA11190703 SGV19254031HA 010084068210413521SGV19254031HA11190618 SGV19254037HA 010084068210413521SGV19254037HA11190618 SGV19254039HA 010084068210413521SGV19254039HA11190618 SGV19294002HA 010084068210413521SGV19294002HA11190717 SGV19294004HA 010084068210413521SGV19294004HA11190717 SGV19294007HA 010084068210413521SGV19294007HA11190717 SGV19294008HA 010084068210413521SGV19294008HA11190717 SGV19274008HA 010084068210413521SGV19274008HA11190703 SGV16314022HA 010084068210413521SGV16314022HA11160801 SGV19264006HA 010084068210413521SGV19264006HA11190626 SGV19264014HA 010084068210413521SGV19264014HA11190626 SGV19264018HA 010084068210413521SGV19264018HA11190626 SGV19264019HA 010084068210413521SGV19264019HA11190626 SGV19264021HA 010084068210413521SGV19264021HA11190626 SGV19264023HA 010084068210413521SGV19264023HA11190626 SGV19264024HA 010084068210413521SGV19264024HA11190626 SGV19264028HA 010084068210413521SGV19264028HA11190626 SGV19264034HA 010084068210413521SGV19264034HA11190626 SGV19264037HA 010084068210413521SGV19264037HA11190626 SGV19264040HA 010084068210413521SGV19264040HA11190626 SGV19264041HA 010084068210413521SGV19264041HA11190626 SGV19264043HA 010084068210413521SGV19264043HA11190626 SGV19264046HA 010084068210413521SGV19264046HA11190626 SGV19264048HA 010084068210413521SGV19264048HA11190626 SGV19264056HA 010084068210413521SGV19264056HA11190626 SGV19264060HA 010084068210413521SGV19264060HA11190626 SGV19264027HA 010084068210413521SGV19264027HA11190626 SGV19264032HA 010084068210413521SGV19264032HA11190626 SGV19264038HA 010084068210413521SGV19264038HA11190626 SGV19264050HA 010084068210413521SGV19264050HA11190626 SGV19264059HA 010084068210413521SGV19264059HA11190626 SGV19294016HA 010084068210413521SGV19294016HA11190717 SGV19264029HA 010084068210413521SGV19264029HA11190626 SGV19274024HA 010084068210413521SGV19274024HA11190703 SGV19274028HA 010084068210413521SGV19274028HA11190703 SGV19274032HA 010084068210413521SGV19274032HA11190703 SGV19274033HA 010084068210413521SGV19274033HA11190703 SGV19274037HA 010084068210413521SGV19274037HA11190703 SGV19274038HA 010084068210413521SGV19274038HA11190703 SGV19274040HA 010084068210413521SGV19274040HA11190703 SGV19274041HA 010084068210413521SGV19274041HA11190703 SGV19254027HA 010084068210413521SGV19254027HA11190618 SGV19254036HA 010084068210413521SGV19254036HA11190618 SGV17419612HA Not Applicable SGV16434022HA Not Applicable SGV19269615HA 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 59 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.
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