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Terminated

Stockert 70 Radio Frequency Ablation Generator

FDA Recall Z-1328-04 · Posted 2004-08-07

Recalling FirmBiosense Webster, Inc.
Recall StatusTerminated
Product CodeDRF
Date Initiated2004-07-16
Date Terminated2012-05-07
Product Quantityunknown, not stated.

Reason for Recall

Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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