FDA Device recall Z-0897-2021
Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-r…
- FDA Device
- Class II
- terminated
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-r… by Respironics California, citing ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended peri….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0897-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-30 |
| Published | 2021-02-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Respironics California |
| Distribution | US |
Product
Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Reason
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Identifiers
| code_info | Model: V60 Ventilator, Part Number 1137276 V60 Ventilator, Intl Opt CFLEX, AVAPS 3.00 SW Serial Numbers: 100286055…Model: V60 Ventilator, Part Number 1137276 V60 Ventilator, Intl Opt CFLEX, AVAPS 3.00 SW Serial Numbers: 100286055 100286057 100286203 100286204 100286207 100289426 100289690 100289701 100289702 100289703 100289704 100289711 100291365 100291472 100291487 100291842 100309654 100309725 100309726 100309728 100311169 100311171 100314702 100315038 100318590 100318593 100318613 100319271 100319286 100319296 100319298 100319300 100329969 100329972 100329979 100337251 100339218 100340917 100341273 100345558 100345603 100369688 100377935 100284364 100284366 100286200 100286201 100286202 100286206 100288337 100289430 100289495 100289498 100289684 100289700 100291197 100291363 100291364 100291370 100291468 100291473 100291474 100291724 100291732 100291825 100291833 100291837 100309647 100309649 100309653 100317131 100317280 100320643 100321695 100321704 100329980 100329985 100329990 100341375 100376390 100378223 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0897-2021%22
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