Recall Z-1123-2009 ยท GDC Table, Operating-Room, Electrical
Berchtold Corp.
Operon Electrical Operating Room Table. The device is used as an electrical operating room table.
| Date | Apr 27, 2009 (initiated Feb 2, 2009) |
| Status | Terminated |
| Reason | Difficulty in pressing the button needed to release a bed part resulted in an injury to a caregiver's finger which became stuck in metal latch under the gas cylinder of the bed piece. |
| Root cause | Device Design |
| Action | An official notification letter dated February 3, 2009 was hand-carried by a local Berchtold Corporation Technical Service representative to each account. The letter indicated that the Berchtold Corporation Service Technician will complete recommended upgrades. Direct questions concerning this recall to your BERCHTOLD Technician Service at 1-800-243-5135 and press the Number 2. |
| Quantity | 453 units |
| Distribution | Worldwide Distribution -- US and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.