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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01024-1
Product Name/Description Mobile Detector Holder for DigitalDiagnost System (Digital diagnostic x-ray System). Models: Single Detector, Dual Detector, Release 3

System codes: 712020, 712022 & 712025

ARTG Number: 117662
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 10/10/2012
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue The Wireless Portable Detector is fixed in the Mobile Detector Holder via a lock mechanism. The 4 countersunk screws, that are used to attach the lock, mechanism, can become loose. If this happens and the mechanism fails, the detector may fall down when the holder is rotated 90 degrees clockwise.
Recall Action Recall for Product Correction
Recall Action Instructions The user should control the lock mechanism of the Mobile Detector Holder. In case the lock mechanism can be moved without pressing the actuator, the holder should not be rotated Clockwise. Philips Healthcare will secure the 4 countersunk screws, which are used to attach the lock mechanism, with thread locker (e.g. LOCTITE 243).
Contact Information 1800 251 400 - Philips Customer Care Centre