Respironics V60 Ventilator User Interface Kits Recalled for Touchscreen Failure
Respironics is recalling V60 Ventilator User Interface kits because the touchscreen may freeze, preventing clinicians from adjusting therapy settings.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that the defect may result in hypercarbia and/or hypoxemia, which are significant physiological injuries.
Plain-English summary
Respironics California, LLC is recalling 56 units of Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits. The affected products are identified by specific reference and part numbers, including 453561528931, 453561528941, 453561536451, and 453561536461, and are associated with a list of 56 specific serial numbers.
The recall is due to a defect where the ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with the unresponsive touchscreen. Consequently, a clinician would have no prior indication of the failure and would be unable to change ventilator settings. While the ventilator continues to function at predetermined settings, a delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
The products were distributed in the United States and in numerous foreign countries, including Australia, Canada, China, Germany, and the United Kingdom. Clinicians and facilities should check their inventory for the affected serial numbers and contact Respironics for further instructions on the recall.
The recalled product
- Product
- Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461
- Manufacturer
- Respironics California, LLC
- Category
- Medical Device — Ventilator
- Affected units
- 56
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: 100270400
- 100270407
- 100256220
- 100270404
- 100263004
- 100266507
- 100270402
- 100263001
- 100263009
- 100258193
- 100258197
- 100258883
- 100262978
- 100263006
- 100258196
- 100256196
- 100256197
- 100256198
- 100263003
- 100266499
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Respironics California, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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