Saint Paul, MN, United States
Abbott Laboratories Inc. (St Jude Medical) recalls
3 recalls recorded since 2018, most recently on 5 May 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 5 May 2021
- Terminated
- 18 June 2024
- Reason
- Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
- Distribution
- US Nationwide distribution in the states of MI, KS, MO, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1854-2021, Z-1855-2021, Z-1853-2021
- v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficie
- WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
- v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture,
Terminated Class II Medical devices
- Recall started
- 22 April 2021
- Terminated
- 2 February 2023
- Reason
- Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.
- Distribution
- US and AUSTRALIA, EGYPT, SOUTH AFRICA, BELGIUM, COLOMBIA, UNITED KINGDOM, COSTA RICA, ISRAEL, SOUTH KOREA, SINGAPORE, TAIWAN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1549-2021
- NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Terminated Class II Medical devices
- Recall started
- 5 April 2019
- Terminated
- 27 April 2021
- 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.
- Distribution
- US, UNITED KINGDOM, UAE, TURKEY, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDIA ARABIA, RUSSIA, ROMANIA, PORTUGAL, POLAND, PALESTINE, OMAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MALAYSIA, LEBANON, JORDAN, JAPAN, ITALY, ISRAEL, IRE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1493-2019
- TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.