Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0554-2007

Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East...

STERIS Corporation / initiated 2007-02-06 / Terminated / root cause: supplier

Steris Corporation began a recall of Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, Montgomery, AL 36109 USA, TEL: 334 277 6660, FAX: 334 271... on . The reason FDA records is "A variation in suppliers welding processes, at the inner section of the hydraulic lift column, of the surgical table, may result in the table top becoming unstable, which could result in injury to patients or staff". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number
Z-0554-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
STERIS Corporation
Product
Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, Montgomery, AL 36109 USA, TEL: 334 277 6660, FAX: 334 271 5450
Product code
GDC Table, Operating-Room, Electrical
Reason for recall
A variation in suppliers welding processes, at the inner section of the hydraulic lift column, of the surgical table, may result in the table top becoming unstable, which could result in injury to patients or staff.
Root cause tag
supplier
FDA root cause
Other
Action
A certified letter was sent to all affected consignees on February 6, 2007 notifying them of the issue and informing them of the recall and the replacement of the affected tables with new tables.
Quantity in commerce
46 tables
Distribution
USA and Canada
Product codes and lots
Serial Numbers: C429106030 through C436306020