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S-ICD System - Q-Tech Programmer
- Starting date:
- January 12, 2017
- Posting date:
- January 24, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61926
Reason
The potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-CID to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer. There is no risk of this behavior occurring when the latitude patient management system communicates with an S-ICD in an ambulatory setting.
Affected products
S-ICD System - Q-Tech Programmer
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 3200
Companies
- Manufacturer
-
Cardiac Pacemakers Incorporated
4100 Hamline Avenue North
St. Paul
55112
UNITED STATES