Recall Z-1493-2019 ยท OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Abbott Laboratories Inc. (St Jude Medical)
TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
| Date | Apr 5, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | The recall notice, and clinician acknowledgment form were hand delivered by Abbott Sales Representatives to all impacted accounts starting April 5, 2019. Completed Clinician Acknowledgement Forms, signify they received the correction notification for the impacted TactiSys Quartz Equipment with software version 1.7. |
| Quantity | 317 units |
| 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, IRELAN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.