CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
FDA Recall Z-2883-2020 · Posted 2020-08-24
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeCBK
Date Initiated2020-07-14
Date Terminated2024-09-23
Product Quantity2277 units
Reason for Recall
The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
Firm Action
On July 14th, 2020 the firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 7/14/2020 to its customers with the following instructions:
Safety Instructions
You may continue to use the CARESCAPE R860 Ventilator. Ensure that the FiO2 alarm limit is set to the factory default limit +/- 6 % so that the clinician is aware if the measured value differs from set value. When making an extubation decision, use the set FiO2 value instead of the FiO2 measured by the oxygen sensor.
The user can use other methods to measure FiO2 or switch to another device and call GE Healthcare.
Product Correction:
GE Healthcare will correct all affected units at no cost to you. A GE Healthcare representative will contact you to arrange for the correction.
Contact Information:
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.
Root Cause
Process control
Distribution Pattern
Domestic Distribution: USA International Distribution: Australia, Bahrain, Bermuda, Canada, Egypt, France, Germany, Honduras, India, Iraq, Italy, Lebanon, Mexico, Panama, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Taiwan and United Arab Emirates.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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