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STERRAD NX STERILIZATION SYSTEM (2015-09-25)
- Starting date:
- September 25, 2015
- Posting date:
- October 22, 2015
- 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-55526
Affected Products
STERRAD NX STERILIZATION SYSTEM
Reason
Advanced Sterilization Products (ASP) has recently determined the current STERRAD NX System is exceeding the electromagnetic compatibility class radiated emissions specification limit by 20 decibel micro-volt per meter, which equates to 0.001 volt per meter at a distance of 10 meters. The risk is assessed as low for interference to active implantable and wearable devices and other nearby electrical equipment.
Affected products
STERRAD NX STERILIZATION SYSTEM
Lot or serial number
1033141070
1033142147
1033150098
33130233
33130236
33140013
33140023
33140064
Model or catalog number
10033
Companies
- Manufacturer
-
Advanced Sterilization Products
A Division of Ethicon
33 Technology Drive
Irvine
92618
California
UNITED STATES