Recall record at a glance
| Official record | Z-2260-2012 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Respironics California Inc. |
| Report date | Sep 12, 2012 |
| Recall initiation date | Jul 31, 2012 |
| Quantity | 197 units total (116 in the US) |
| Location | Carlsbad, CA, United States |
Official product description
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.
Why the product was recalled
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
Distribution information
Worldwide Distribution - US (Nationwide) and the countries of: Australia, Belgium, Canada, China, Germany, Italy, Japan, Kuwait, Netherlands, Norway. Qatar, Saudi Arabia, Turkey, and United Kingdom.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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