Stockert 70 Radio Frequency Ablation Generator
FDA device recall Z-1328-04 · posted 2004-08-07 · Terminated
Recall details
- Recalling firm
- Biosense Webster, Inc.
- Reason for recall
- Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRF
- Quantity affected
- unknown, not stated.
- Distribution
- Nationwide
- Date initiated
- 2004-07-16
- Date posted
- 2004-08-07
- Date terminated
- 2012-05-07
- Location
- Irwindale, CA
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