Recall Z-0124-06 ยท DTA Tester, Pacemaker Electrode Function
Remington Medical Inc.
Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile * Manufactured by Remington Medical Incorporated, 6830 Meadowridge Court, Alpharetta, GA 30005, (770) 888-8520 or (800) 999-0057 * Distributed By: Guidant Corporation, 4100 Hamine Avenue North, St. Paul, MN 55112-5798 USA.
| Date | Nov 3, 2005 (initiated Aug 31, 2005) |
| Status | Terminated |
| Reason | The vector selector has an electrical design flaw which prevents RV pacing. |
| Root cause | Other |
| Action | Guidant Corporation notified Remington Medical of the problem. Remington had instructed Guidant to retrieve the product from their sales force by 09/07/2005 and return to Remington by 09/09/2005. |
| Quantity | 600 units |
| Distribution | MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050884 | ADAPTER CABLE Remington Medical, Inc., May 19, 2005 |