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
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