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Shockpulse Lithotropsy Generator
- Starting date:
- November 30, 2016
- Posting date:
- January 6, 2017
- 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-61568
Reason
Revised labeling- the rating label on the back of the ultrasonic generator specifies a voltage range of 100V to 240V , and based on tests this needs to be revised to 100V to 150V.
Affected products
Shockpulse Lithotropsy Generator
Lot or serial number
CG0032
CG0059
CG0129
CG0131
CG0158
Model or catalog number
SPL-G
Companies
- Manufacturer
-
Cybersonics Inc.
5340 Fryling Road, Suite 101
Erie
16510
Pennsylvania
UNITED STATES