—#50396

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

FDA product code: GDC — Table, Operating-Room, Electrical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Serial Numbers: C429106030 through C436306020

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 2720 Gunter Park Drive East, Montgomery, Alabama 36109-1410

Distribution

Distribution pattern: USA and Canada

Timeline

Recall initiated: 2007-02-06
Posted by FDA: 2007-02-23
Terminated: 2009-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50396. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.