| |
Class 2 Device Recall Ronci |
 |
| Date Initiated by Firm |
November 06, 2003 |
| Date Posted |
December 10, 2003 |
| Recall Status1 |
Terminated 3 on July 25, 2005 |
| Recall Number |
Z-0182-04 |
| Recall Event ID |
27655 |
| Product Classification |
Board, Bed - Product Code FPS
|
| Product |
Ronci Surgical Universal Imaging Extension used with the Ronci Pain Management Table System
Catalog Number: R-934-25A |
| Code Information |
S/N''S: R00043, R001080, R001092, R001198, R0001341, R001370, R001374, R001366, R001337, R001497, R001478, R001493, R001501, R001529, R001812, R001816, R002023. |
Recalling Firm/
Manufacturer |
The OR Group
531 Main St
Acton MA 01720-3934
|
| For Additional Information Contact |
Nancy Royalty
877-458-4884 Ext. 280
|
Manufacturer Reason
for Recall |
Imaging table with extension may fail if the table leg is incorrectly positioned and the load exceeds the maximum weight of 400 lb
|
FDA Determined
Cause 2 |
Other |
| Action |
The OR Group forwarded by 2nd day mail on 11/6/03 the repair kit and instructions to the accounts. |
| Quantity in Commerce |
17 units |
| Distribution |
Nationwide.
CA, FL, GA, IA MI, MT, NH, OH, NJ, NY, SC, UT, TX, VA |
| Total Product Life Cycle |
TPLC Device Report
|
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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.
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