Recall Z-2883-2020 ยท CBK Ventilator, Continuous, Facility Use
GE Healthcare, LLC
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.
| Date | Aug 24, 2020 (initiated Jul 14, 2020) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| 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. |
| Quantity | 2277 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142679 | CARESCAPE R860 Datex-Ohmeda, Inc., Jun 12, 2015 |