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Digital Diagnost (2015-04-17)
- Starting date:
- April 17, 2015
- Posting date:
- May 8, 2015
- 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-53291
Recalled Products
A. Digital Diagnost
Reason
The system is designed to emit an acoustic signal (beep) upon termination of an exposure. Philips has become aware that if the system has been powered on for more than 12 hours, the system will no longer emit this signal. This signal is a requirement as per IEC 60601-1-3, clause 6.4.2 and the radiation emitting devices regulations C.R.C., CH. 1370, part xii, section 6 (g).
Affected products
A. Digital Diagnost
Lot or serial number
63902199
64281306
64489207
64932287
64932353
64932354
Model or catalog number
9890 010 83904
Companies
- Manufacturer
-
Philips Medical Systems Dmc Gmbh
Rontgenstrabe 24
Hamburg
22335
GERMANY