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DURADIAGNOST (2016-05-03)
- Starting date:
- May 3, 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-58416
Affected Products
DURADIAGNOST
Reason
A firmware anomaly inside the detector (PX4343RG) can cause the detector to appear ready for acquisition on very short time intervals while it actually is not, resulting in not correctly acquiring the x-ray image.
Affected products
DURADIAGNOST
Lot or serial number
- SN150002
Model or catalog number
- 9897-010-02021
Companies
- Manufacturer
-
PHILIPS HEALTHCARE (SUZHOU) CO., LTD
NO. 258, ZHONG YUAN ROAD
SUZHOU
215024
CHINA