Recall Z-1493-2019— Abbott Laboratories Inc. (St Jude Medical)
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories Inc. (St Jude Medical), initiated 2019-04-05, terminated 2021-04-27. FDA's recall record names no specific 510(k) clearance for this event. Product: TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP). Reason: 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..
- Recalling firm
- Abbott Laboratories Inc. (St Jude Medical)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-05
- Terminated
- 2021-04-27
- Firm location
- Saint Paul, MN, United States
Product description
TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.