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U.S. Department of Health and Human Services

Class 1 Device Recall CARESCAPE Respiratory Module EsCAiOVE

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  Class 1 Device Recall CARESCAPE Respiratory Module EsCAiOVE see related information
Date Initiated by Firm September 27, 2019
Create Date January 10, 2020
Recall Status1 Completed
Recall Number Z-0759-2020
Recall Event ID 84034
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product CARESCAPE Respiratory Module E-sCAiOVE
Code Information Mfg. Lot or Serial # SGV19295006HA 010084068210430221SGV19295006HA11190717 SGV19255001HA 010084068210430221SGV19255001HA11190618 SGV19295019HA 010084068210430221SGV19295019HA11190717 SGV19255002HA 010084068210430221SGV19255002HA11190618 SGV19255004HA 010084068210430221SGV19255004HA11190618 SGV19255010HA 010084068210430221SGV19255010HA11190618 SGV19255017HA 010084068210430221SGV19255017HA11190618 SGV19255019HA 010084068210430221SGV19255019HA11190618 SGV16385015HA 010084068210430221SGV16385015HA11160919 SGV15285005HA Not Applicable SGV19285017HA 010084068210430221SGV19285017HA11190710 SGV19285019HA 010084068210430221SGV19285019HA11190710 SGV19285007HA 010084068210430221SGV19285007HA11190710 SGV19259708HA Not Applicable  
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
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 14 unit
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.