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Ellipse VR and Ellipse DR (2014-08-20)
- Starting date:
- August 20, 2014
- Posting date:
- September 3, 2014
- 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-41259
Recalled Products
A) Ellipse VR
B) Ellipse DR
Reason
There is a potential anomaly which may result in delayed delivery of high voltage therapy or prevent delivery of part or all of a programmed high voltage therapy shock. The anomaly most commonly presents as a vibratory patient notification and upon interrogation, a programmer or Merlin.Net alert indicating a "capacitor charge time limit reached" message. This may occur during capacitor maintenance or charging for high voltage therapy.
Affected products
A) Ellipse VR
Lot or serial number
All serial numbers.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
St. Jude Medical
Cardiac Rhythm Management Division
15900 Valley View COurt
Sylmar
91342
California
UNITED STATES
B) Ellipse DR
Lot or serial number
All serial numbers.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
St. Jude Medical
Cardiac Rhythm Management Division
15900 Valley View COurt
Sylmar
91342
California
UNITED STATES