Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1493-2019 — TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)

U.S. FDA — Device Enforcement · United States · 2019-04-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1493-2019
Date of alert
2019-04-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Laboratories Inc. (St Jude Medical)
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07640157990194
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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