FDAApril 5, 2019device

TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may lead to intermittent contact force data to be displayed during the procedure.

What to do

FDA enforcement status: Terminated

Brands named

abbott laboratories inc st jude medicalabbottabbott laboratories

UPCs

07640157990194

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP) — Recall Details · AllClear