Recall record at a glance
| Official record | Z-0485-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Respironics California Inc. |
| Report date | Dec 3, 2014 |
| Recall initiation date | Oct 29, 2014 |
| Quantity | 3,943 units total (3,071 units in US) |
| Location | Carlsbad, CA, United States |
Official product description
Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.
Why the product was recalled
If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted.
Distribution information
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Italy, Korea, Lebanon, Malaysia, Mexico, Pakistan, Panama, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.
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: 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
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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