TactiSys Quartz Equipment (2019-04-24)
- Starting date:
- April 24, 2019
- Posting date:
- May 10, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69884
Last updated: 2019-05-10
Affected Products
TactiSys Quartz Equipment
Reason
Device operating on software v1.7.0 may display intermittent contact force data during procedures. The device log data fills the allocated disk space, which prevents the storage on new log data. In such instances, the contact force information is displayed in purple indicating that the data is not current and may not be accurate. This data will remain purple until communication is re-established or the disk has room to store log files.
Affected products
TactiSys Quartz Equipment
Lot or serial number
Not applicable.
Model or catalog number
PN-004 400
Companies
- Manufacturer
-
St. Jude Medical, Inc
One St. Jude Medical Drive
Saint Paul
55117
Minnesota
UNITED STATES