Recall Z-0827-2016— Draeger Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by Draeger Medical, Inc., initiated 2016-02-04, terminated 2020-04-01. It names 2 FDA 510(k) clearances: K093632, K093633. Product: Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.. 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..
- Recalling firm
- Draeger Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-02-04
- Terminated
- 2020-04-01
- 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
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.