Recall record at a glance
| Official record | Z-1493-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Abbott Laboratories Inc. (St Jude Medical) |
| Report date | Jun 5, 2019 |
| Recall initiation date | Apr 5, 2019 |
| Quantity | 317 units |
| Location | Saint Paul, MN, United States |
Official product description
TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
Why the product 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.
Distribution information
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, IRELAND, IRAN, GREECE, GERMANY, FRANCE, EL SALVADOR, EGYPT, DENMARK, Czech Republic, CHINA, CANADA, BULGARIA, BELGIUM, AUSTRIA, AUSTRALIA
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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