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INGENUITY CT SYSTEM (2016-04-26)
- Starting date:
- April 26, 2016
- Posting date:
- May 16, 2016
- 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-58424
Affected Products
INGENUITY CT SYSTEM
Reason
Two different length fasteners were found to be made of stainless steel rather than the specified alloy steel. The nonconforming fasteners continue to meet the tensile safety factor requirements for the application. However given the material characteristics of stainless steel, these fasteners may not be reused (re-torqued).
Affected products
INGENUITY CT SYSTEM
Lot or serial number
Not applicable
Model or catalog number
- 728323
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 MINER ROAD
CLEVELAND
Ohio
UNITED STATES