Reported Jun 5, 2019 · Terminated
TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367…
Abbott Laboratories Inc. (St Jude Medical)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories Inc. (St Jude Medical) · One St. Jude Medical Drive · Saint Paul, MN · 55117
Is this the product you have?
- TactiSys Quartz Equipment (with software version 1.7)
- ModelPN-004 400
- Part Numbers
600043767 (China)100154367 (Global)100154368 (SWAP)
- Lot codes and dates
- UDI07640157990194
- Serial Numbers
328 of 328 codes
330193305933350333543335733360333613336333390333923339333405334173342133444334493345133457334583346133491334923350933013330153302033040330753309133097331603319733384333853338733389334143343333388334353348133154331573316233163332783309233159334373341233014330273302833029330383304933057330823309633192
- Amount recalled
- 317 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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