Date Initiated by Firm | August 20, 2010 |
Date Posted | October 01, 2010 |
Recall Status1 |
Terminated 3 on September 27, 2012 |
Recall Number | Z-2642-2010 |
Recall Event ID |
56593 |
Product Classification |
Laparoscope, General & Plastic Surgery - Product Code GCJ
|
Product | Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment) |
Code Information |
Models: OTV-S7H-1D-L08E and OTV-S7H-1D-F08E; serviced by recalling firm from 3/03 to 9/07 |
Recalling Firm/ Manufacturer |
Olympus America Inc. 3500 Corporate Pkwy. P.O. Box 610 Center Valley PA 18034-0610
|
For Additional Information Contact | Laura Storms-Tyler 484-896-5688 |
Manufacturer Reason for Recall | Mislabeled. Endoscopic body-type camera heads labeled as cardiac-type. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | Asked consignees to return camera heads to correct the labeling. |
Quantity in Commerce | 217 camera heads |
Distribution | nationwide; camera heads were serviced and returned to consignees in March 2003 - September 2007 timeframe |
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.
|