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