FDA Device recall Z-0903-2021
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-r…
- FDA Device
- Class II
- ongoing
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-r… by Respironics California, citing potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0903-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-11-02 |
| Published | 2021-02-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Respironics California |
| Distribution | US |
Product
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Reason
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Identifiers
| code_info | Model: V60 Part Number: 1053614 V60 Ventilator,Intl Opt: CFLEX,AVAPS Serial numbers: 100007217 100021204 100021286 100…Model: V60 Part Number: 1053614 V60 Ventilator,Intl Opt: CFLEX,AVAPS Serial numbers: 100007217 100021204 100021286 100021400 100029451 100042750 100042939 100043085 100055703 100056018 100062163 100062178 100063153 100063155 100063162 100063293 100063300 100069697 100069744 100069860 100070577 100070772 100132058 100133634 100144871 100144874 100144879 100144961 100144982 100162731 100162792 100169641 100195675 100219970 100219972 100219975 100219999 100220001 100221150 100239619 100243227 100246517 100247269 100252596 100252597 100252600 100252764 100252768 100252771 100252772 100252773 100252797 100253477 100253484 100253492 100253493 100253494 100253500 100254739 100286208 100286300 100311170 100317381 100317392 100318233 100318405 100318406 100318408 100318413 100318415 100318416 100318426 100318615 100318623 100336755 100336849 100336855 100336889 100336895 100336900 100337085 100337258 100337260 100337261 100343560 100344202 100344235 100350181 100350684 100350711 100350714 1003 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0903-2021%22
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