Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
FDA device recall Z-0827-2016 · posted 2016-02-25 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 2553
- Distribution
- US Nationwide Distribution including Puerto Rico.
- Date initiated
- 2016-02-04
- Date posted
- 2016-02-25
- Date terminated
- 2020-04-01
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE (K093632) | Drager Medical AG & Co. Kgaa | 2010-04-05 |
| INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE (K093633) | Draegerwerk AG & CO Kgaa | 2010-03-30 |