Respironics V680 Ventilator Recalled for Unresponsive Touchscreen
Respironics is recalling 190 V680 Ventilators because the touchscreen may freeze, preventing clinicians from adjusting therapy settings and potentially causing delayed treatment.
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 therapy, 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 190 units of the Respironics V680 Ventilator, Service # 850011. The recall affects units distributed in the United States and numerous foreign countries, including Australia, Canada, China, and the United Kingdom.
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 the unresponsive touchscreen, meaning the 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.
Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Clinicians should monitor patients for signs of hypercarbia or hypoxemia and be prepared to manually manage ventilation if the touchscreen becomes unresponsive.
The recalled product
- Product
- Respironics V680 Ventilator, Service # 850011, (OUS Only)
- Manufacturer
- Respironics California, LLC
- Category
- Medical Device — Ventilator
- Affected units
- 190
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: 100255874
- 100255957
- 100257487
- 100257488
- 100257490
- 100257491
- 100257493
- 100257494
- 100257495
- 100257496
- 100257497
- 100257498
- 100257499
- 100257500
- 100257501
- 100258060
- 100258061
- 100258063
- 100258064
- 100258065
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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