Recall Z-0436-2016— Draeger Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by Draeger Medical, Inc., initiated 2015-12-01, terminated 2020-04-03. It names 2 FDA 510(k) clearances: K093632, K093633. Product: Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.. Reason: 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..
- Recalling firm
- Draeger Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-12-01
- Terminated
- 2020-04-03
- Firm location
- Telford, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K093632 — INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE
- K093633 — INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.