Recall Z-1328-04 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Biosense Webster, Inc.
Stockert 70 Radio Frequency Ablation Generator
| Date | Aug 7, 2004 (initiated Jul 16, 2004) |
| Status | Terminated |
| Reason | Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction. |
| Root cause | Other |
| Action | Customers were instructed to suspend use of the generators with software version 1.033 until they are upgraded with version 1.034B in a letter dated 7/15/2004. Firm issued a second letter on 9/17/04 for a software error discovered in-house during the upgrade. It instructs a workaround solution to prevent unwanted activity of the catheter. |
| Quantity | unknown, not stated. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.