Autolith Lithotripter System - Probes (2020-03-16)
- Starting date:
- March 16, 2020
- Posting date:
- April 17, 2020
- 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-72797
Last updated: 2020-04-17
Affected Products
Autolith Lithotripter System - Probes
Reason
The devices are being recalled as part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Affected products
Autolith Lithotripter System - Probes
Lot or serial number
- NK12511
- NK12801
Model or catalog number
- 9-195-371DS
Companies
- Manufacturer
-
Northgate Technologies Inc.
1591 Scottsdale Court
Elgin
60123
Illinois
UNITED STATES