| Class 2 Device Recall Cmax Surgical Table | |
Date Initiated by Firm | February 06, 2007 |
Date Posted | February 23, 2007 |
Recall Status1 |
Terminated 3 on September 11, 2009 |
Recall Number | Z-0554-2007 |
Recall Event ID |
37349 |
Product Classification |
Surgical Table - Product Code GDC
|
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 |
Code Information |
Serial Numbers: C429106030 through C436306020 |
Recalling Firm/ Manufacturer |
Steris Corporation 2720 Gunter Park Drive East Montgomery AL 36109-1410
|
For Additional Information Contact | Holly Wright Lee 440-392-7019 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|