V60 Ventilator — Class I medical device recall Z-2260-2012
Terminated recall by Respironics California Inc, reported 2012-09-12, distributed nationwide. Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may
| Recall number | Z-2260-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Respironics California Inc, Carlsbad, CA, United States |
| Recall initiated | 2012-07-31 |
| Classified | 2012-08-31 |
| Reported by FDA | 2012-09-12 |
| Terminated | 2013-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CN, DE, GB, IT, JP, KW, NL, NO, QA, SA, TR |
| Quantity | 197 units |
| Model numbers | 1056490, V60 |
Product
V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
Reason for recall
Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilatio
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.