Recall Z-0827-2016 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
| Date | Feb 25, 2016 (initiated Feb 4, 2016) |
| Status | Terminated |
| Reason | The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device. |
| Root cause | Software design |
| Action | Draeger Medical, Inc. will send an Urgent Medical Device Recall Letter to consignees in a method that confirms delivery. For consignees that have received new devices with firmware version 1.50 (127 devices) or through device updates (644 devices; reference Recall Z-0436-2016), those devices will be downgraded to firmware version 1.49 and the batteries replaced. Batteries will continue to be replaced for all consignees every six months until a final solution is available. |
| Quantity | 2553 |
| Distribution | US Nationwide Distribution including Puerto Rico. |
| FDA record | Open on fda.gov |