ClearanceBrief
Recall Z-0554-2007 ยท GDC Table, Operating-Room, Electrical

Steris Corporation

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

DateFeb 23, 2007 (initiated Feb 6, 2007)
StatusTerminated
ReasonA 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 causeOther
ActionA 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.
Quantity46 tables
DistributionUSA and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.