Sonopet Main Unit, Universal, and Universal Handpiece (2018-03-12)
- Starting date:
- March 12, 2018
- Posting date:
- April 3, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66330
Affected products
- Sonopet Main Unit
- Sonopet Universal
- Sonopet Universal Handpiece
Reason
Ultrasonic surgical aspirator devices use an oscillating tip to cause tissue fragmentation through the delivery of ultrasound energy to target tissue. The potential for tissue dissemination is mitigated, but not completely eliminated, by the use of suction/aspiration. Industry-wide IFU update initiated by the FDA. Adding the contraindication: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.
Affected products
-
Sonopet Main Unit
Lot or serial number
All lots.
Model or catalog number
5450-850-000
Companies
- Manufacturer
-
Stryker Medtech K.K.
1131-1 Higashi-naganuma
Inagi,Tokyo-To
206-0802
JAPAN
B. Sonopet Universal
Lot or serial number
All lots.
Model or catalog number
5450-820-000
Companies
- Manufacturer
-
Stryker Medtech K.K.
1131-1 Higashi-naganuma
Inagi,Tokyo-To
206-0802
JAPAN
C. Sonopet Universal Handpiece
Lot or serial number
All lots.
Model or catalog number
5450-840-000
Companies
- Manufacturer
-
Stryker Medtech K.K.
1131-1 Higashi-naganuma
Inagi,Tokyo-To
206-0802
JAPAN