FDA Device recall Z-0912-2021
Philips Respironics V60 Ventilator Part Number 1076717 - 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 1076717 - 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-0912-2021 |
| 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 1076717 - 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: 1076717 V60 Ventilator, CHINA OPT: NONE Serial Numbers: 100033299 100033300 100033301…Model: V60 Part Number: 1076717 V60 Ventilator, CHINA OPT: NONE Serial Numbers: 100033299 100033300 100033301 100033302 100033303 100033304 100033305 100033306 100033308 100033309 100033310 100033311 100033312 100033313 100033314 100033315 100033316 100033317 100033318 100033319 100033320 100033321 100033322 100033323 100033562 100033563 100033564 100033565 100033566 100033567 100033568 100033569 100033570 100033571 100033572 100033573 100033574 100033575 100033576 100033577 100033578 100033579 100033580 100033581 100033582 100033583 100033584 100033585 100033586 100033587 100033588 100033589 100033590 100033591 100033592 100033593 100033594 100033595 100033645 100033646 100033647 100033648 100033649 100033650 100033651 100033652 100033653 100033654 100033730 100033731 100033732 100033733 100033734 100033735 100033736 100033737 100033738 100033739 100033740 100033741 100033742 100033743 100033744 1 |
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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-0912-2021%22
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