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Philips DuraDiagnost X-ray System (2016-06-22)
- Starting date:
- June 22, 2016
- Posting date:
- July 19, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-59376
Affected products
A. Philips DuraDiagnost X-ray System
Reason
DuraDiagnost systems provide an audible exposure termination signal (beep) through the speaker integrated into the monitor. Philips has become aware that buttons or keys on the monitor allow the user to turn the volume setting down to "0", in which case the beep will not be heard at the conclusion of an exposure. Note that the current volume setting is displayed when the buttons or keys are depressed.
Affected products
A. Philips DuraDiagnost X-ray System
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