Respironics V60 Ventilator Recalled for Frozen Touchscreen Failure
Respironics is recalling 2,851 V60 Ventilators because the touchscreen may freeze, preventing clinicians from adjusting therapy settings. This could delay necessary changes, potentially leading to hypercarbia or hypoxemia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (hypercarbia/hypoxemia) due to inability to adjust settings, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Respironics California, LLC is recalling 2,851 units of the Respironics V60 Ventilator (Service # 850008, REF: 1053613, 1053614, 1053617). The recall is due to a defect where the ventilator's 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 an unresponsive touchscreen. Consequently, the clinician would have no prior indication of the failure and would be unable to change the ventilator settings. While the ventilator will continue to function at the predetermined and accepted settings required to support the patient, a delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
The affected units were distributed in the United States and in numerous foreign countries, including Australia, Canada, China, Germany, and the United Kingdom. Healthcare facilities and consumers should check their device serial numbers against the list provided in the official recall notice and contact Respironics for further instructions.
The recalled product
- Product
- Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
- Manufacturer
- Respironics California, LLC
- Category
- Medical Device — Ventilator
- Affected units
- 2,851
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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