FDA Device recall Z-0436-2016
Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator
- FDA Device
- Class I
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class I recall of Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator by Draeger Medical, citing 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 unex….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0436-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-12-01 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Draeger Medical |
| Distribution | US |
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.
Identifiers
| code_info | Catalog numbers: 8416400/8417400 distributed June 2011 October 2015. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class I · 2024-12-25 · Draeger Medical - Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anest…
FDA Device · Class I · 2024-12-25 · Draeger Medical - Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
FDA Device · Class I · 2024-11-20 · Draeger Medical - Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
FDA Device · Class I · 2024-11-20 · Draeger Medical - Dr¿ger Perseus A500 Anesthesia Workstation
FDA Device · Class I · 2024-04-24 · Draeger Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0436-2016%22
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