Recall record at a glance
| Official record | Z-1152-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Respironics California, LLC |
| Report date | Feb 19, 2020 |
| Recall initiation date | Sep 11, 2019 |
| Quantity | 2851 |
| Location | Carlsbad, CA, United States |
Official product description
Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
Why the product was recalled
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 an unresponsive touchscreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. 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.
Distribution information
US Nationwide. OUS (Foreign): Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Italy, Malaysia, Mexico, Netherlands, Portugal, Singapore, South Africa, Spain, Sweden, United Arab Emirates, United Kingdom, Viet Nam, Oman, Philippines, Saudi Arabia, Taiwan, Turkey, Russian Federation, Argentina, Ecuador, Poland, Guatemala, Peru, Viet Nam
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: not stated.
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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