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CT Express Hand Switch (2014-04-23)
- Starting date:
- April 23, 2014
- Posting date:
- May 6, 2014
- 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-39347
Recalled products
- CT Express Hand Switch
Reason
The hand switch used with a specific sequence of procedure steps has been observed to intermittently cause the injector to erroneously stay in injection test mode which may alter safety features. Consequently, the injection may result in an over delivery of contrast media equivalent to the programmed post flush volume.
Affected products
A. CT Express Hand Switch
Lot or serial number
Not applicable
Model or catalog number
- 640080
Companies
- Manufacturer
-
Bracco Injeneering S.A.
Avenue De Sevelin 46
Lausanne
1004
SWITZERLAND