FDA Recall
Terminated
Operon Electrical Operating Room Table. The device is used as an electrical operating room table.
Recall: Z-1123-2009
·
Initiated February 2, 2009
Recall
- Recall Number
- Z-1123-2009
- Event Number
- 51276
- Firm
- Berchtold Corp.
- FEI Number
- 1220685
- Product Code
- GDC
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- February 2, 2009
- Posted
- April 27, 2009
- Terminated
- June 4, 2009
- Address
- 1950 Hanahan Rd N, Charleston, SC, 29406-4878
Description
Operon Electrical Operating Room Table. The device is used as an electrical operating room table.
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.
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.
Distribution
Worldwide Distribution -- US and Canada.
Quantity
453 units