Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1123-2009

Operon Electrical Operating Room Table. The device is used as an electrical operating room table

Berchtold Corp. / initiated 2009-02-02 / Terminated / root cause: design

Berchtold Corp. began a recall of Operon Electrical Operating Room Table. The device is used as an electrical operating room table on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1123-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Berchtold Corp.
Product
Operon Electrical Operating Room Table. The device is used as an electrical operating room table.
Product code
GDC Table, Operating-Room, Electrical
Reason for recall
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 tag
design
FDA 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 in commerce
453 units
Distribution
Worldwide Distribution -- US and Canada.
Product codes and lots
D 850, D750, D 752 and B 810.