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MobileDiagnost wDR (2013-09-25)
- Starting date:
- September 25, 2013
- Posting date:
- October 31, 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-36493
Recalled Products
MobileDiagnost wDR
Reason
The instructions for use are being updated to contain tolerances of generator parameters of the MobileDiagnost wDR as required by IEC 60601-1-3 chapter 6.4.3. These required parameters are not present in the current instruction for use of the Mobilediagnost WDR.
Affected products
Mobilediagnost WDR
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 9890 010 8952X
Companies
- Manufacturer
-
Philips Medical Systems DMC GmbH
Rontgenstrabe 24
Hamburg
22335
GERMANY