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Luminos DRF and YSIO (2013-09-02)
- Starting date:
- September 2, 2013
- Posting date:
- September 27, 2013
- 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-35885
Recalled products
- Luminos DRF
- YSIO
Reason
During a RAD examination with automatic exposure control, a highly unlikely malfunction can result in radiation continuing longer than required. This may also result in an overexposed image that is not of diagnostic quality, so that the examination needs to be repeated. Statistically, this malfunction only occurs once every 7000 images and only if images are taken in automatic exposure mode.
Affected products
A. Luminos DRF
Lot or serial number
- 3025
- 3184
- 3190
- 3208
Model or catalog number
- 10094200
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
B. YSIO
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 10281013
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY