Recall record at a glance
| Official record | Z-0996-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | TransMotion Medical Inc. |
| Report date | Jan 28, 2015 |
| Recall initiation date | Nov 14, 2014 |
| Quantity | 1,127 units |
| Location | Sharon Center, OH, United States |
Official product description
Powered stretcher chair used during facial and eye surgeries. One chair per package.
Why the product was recalled
The firm is finding that the stretcher chair controllers are moving the chairs involuntarily.
Distribution information
Worldwide Distribution - US Distribution and the countries including Canada, Australia, Chile, China, Costa Rica, Germany, Algeria, Israel, Italy, South Korea, Malaysia, Nigeria, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Thailand, and Venezuela.
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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