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Sonopet Ultrasonic Aspirator Console (2014-07-03)
- Starting date:
- July 3, 2014
- Posting date:
- July 22, 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-40583
Recalled Products
Sonopet Ultrasonic Aspirator Console
Reason
Manufacturer was aware that lack of irrigation could potentially lead to excessive heat at the tip. Overheating of the tip of the Sonopet system during surgery could lead to cranial injury in a patient.
Affected products
Sonopet Ultrasonic Aspirator Console
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5450-850-000
Companies
- Manufacturer
-
Stryker Medtech K.K.
1131-1 Higashi-naganuma, Inagi,
Tokyo-to
206-0802
JAPAN