Recall Z-0996-2015 ยท GBB Chair, Surgical, Ac-Powered
TransMotion Medical Inc
Powered stretcher chair used during facial and eye surgeries. One chair per package.
| Date | Jan 16, 2015 (initiated Nov 14, 2014) |
| Status | Terminated |
| Reason | The firm is finding that the stretcher chair controllers are moving the chairs involuntarily. |
| Root cause | Component design/selection |
| Action | TransMotion Medical Inc. sent an Urgent Medical Device Recall letter dated November 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: Discontinue use of the device and contact TransMotion Medical Inc. for a replacement. Suspected faulty pendants must be destroyed by severing the cord and discarding the control. Replacement of the pendant is a long-term solution to the issue due to replacement pendants being not of the same type or design as the failed pendant. Accompanying the reca |
| Quantity | 1,127 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.