CLASS I ONGOING Device recall · Reported 9 Mar 2022 · FDA Enforcement Report
Philips Respironics V60 Ventilator recalled by Respironics California
Respironics California is recalling Philips Respironics V60 Ventilator, distributed in 13 states. The recall was initiated on 24 Jan 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0662-2022
- FDA event ID
- 89490
- Recalling firm
- Respironics California, Carlsbad, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 24 Jan 2022
- FDA classified
- 25 Feb 2022
- Reported
- 9 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 24 Jan 2022 | Recall initiated by company | |
| 25 Feb 2022 | Classified by FDA | +32 days |
| 9 Mar 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Philips Respironics V60 Ventilator Part Number 1053617
Where it was distributed
U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A
ArkansasCaliforniaFloridaGeorgiaIndianaLouisianaMarylandMissouriNew YorkPennsylvaniaSouth CarolinaTennesseeTexas
Questions about this recall
Why was it recalled?
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
Which lots are affected?
The Component of the Ventilators that is impacted is: N 1034132 BRACKET, CAPACITOR,MOTOR DRIVER PCB Model V60 Part Number: 1053617 Serial Numbers/UDI Code: MX0016593 / (01)00884838020054(21)MX0016593 MX0016797 / (01)00884838020054(21)MX0016797 MX0016824 / (01)00884838020054(21)MX0016824 MX0016827 / (01)00884838020054(21)MX0016827 MX0016830 / (01)00884838020054(21)MX0016830 MX0016839 / (01)00884838020054(21)MX0016839 MX0016840 / (01)00884838020054(21)MX0016840 MX0016841 / (01)00884838020054(21)MX0016841 MX0016845 (01)00884838020054(21)MX0016845 MX0016853 (01)00884838020054(21)MX0016853 MX0016867 (01)00884838020054(21)MX0016867 MX0016870 (01)00884838020054(21)MX0016870 MX0016871 (01)00884838020054(21)MX0016871 MX0016872 (01)00884838020054(21)MX0016872 MX0016875 (01)00884838020054(21)MX0016875 MX0016878 (01)00884838020054(21)MX0016878
Where was it sold?
U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 89490This product is part of a recall event; the main page for the event is Philips Respironics V60 Plus Ventilator recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Philips Respironics V60 Plus Ventilator recalled | Respironics California | Device Malfunction | 13 states |
More recalls from Respironics California
All 45| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Philips Respironics V60 Ventilator (All recalled | Respironics California | Other | Nationwide |
| Device | CLASS I | Philips Respironics V60 Plus Ventilator (All recalled | Respironics California | Other | Nationwide |
| Device | CLASS I | Philips Respironics V680 Ventilator (All recalled | Respironics California | Other | Nationwide |
| Device | CLASS I | Philips Respironics V60 Plus Ventilator recalled | Respironics California | Device Malfunction | 13 states |
| Device | CLASS I | Philips Respironics V60 Ventilator recalled by Respironics California | Respironics California | Device Malfunction | Nationwide |
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| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |