Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilat
FDA device recall Z-0436-2016 · posted 2015-12-23 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the charging algorithm in the current software. Devices used for patient transport will be a priority.
- Action taken
- Draeger Medical, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated November 2015 to all affected consignees. The letter identified the product, problem, and actions to be taken by the customers. The Battery Charging Software will be updated and, if necessary, the batteries replaced in all affected devices Free of Charge.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 2422
- Distribution
- US Nationwide-including DC and PR, and the states of AK; AR; AZ; CA; CO; CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC;
- Date initiated
- 2015-12-01
- Date posted
- 2015-12-23
- Date terminated
- 2020-04-03
- 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 |