Recall Z-2266-2018 ยท CBK Ventilator, Continuous, Facility Use
Datex-Ohmeda, Inc.
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pr
| Date | Jun 1, 2018 (initiated Dec 8, 2017) |
| Status | Terminated |
| Reason | Potential for the display processor to experience an unexpected failure. |
| Root cause | Software change control |
| Action | On December 12, 2017 GE Healthcare sent letters to their consignees stating that There is a potential for the display processor to experience an unexpected failure. If this failure occurs, the device screen will temporarily go blank and will then display an Error Code EC01 XX. The blank display results in loss of monitored data being displayed to the user. There have been no injuries reported as a result of this issue. You may continue to use the system. Device performance is not affected on devices where no such display failure occurs. In the event this issue occurs, an audible alarm will so |
| Quantity | 349 (US) + 2,051 (OUS) |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AZ, CA, GA, ID, IL, IN, MS, NC, NJ, NK, NV, OH, OK, RI, TX, and WI., and to the countries of : Albania, Argentina, Australia, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142679 | CARESCAPE R860 Datex-Ohmeda, Inc., Jun 12, 2015 |