Reported Mar 9, 2022 · Ongoing
Philips Respironics V60 Ventilator Part Number 1053617
Respironics California, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Respironics California, LLC · 2271 Cosmos Ct · Carlsbad, CA · 92011-1517
Is this the product you have?
- Philips Respironics V60 Ventilator Part Number 1053617
- Lot codes and dates
- The Component
- of the Ventilators that is impacted isN 1034132 BRACKET, CAPACITOR
- MOTOR DRIVER PCB Model V60 Part Number1053617
- Serial Numbers/UDI CodeMX0016593 / (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
- Amount recalled
- 16 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
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).
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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