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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01328-1
Product Name/Description Essenta DR X-ray System (Digital diagnostic X-Ray system)

ARTG Number: 117662
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 17/12/2013
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue If during system installation, the screws holding the C-arm were mounted using thread locking compound (for example, LOCTITE), then the corresponding thread inserts inside the C-arm casting may loosen when the C-arm is dismantled. If after reassembly of the system, the loosened thread inserts become detached from the casting, the C-arm would no longer securely held in position and could fall. The C-arm is most often dismantled and reassembled when the system is moved to another location.
Recall Action Recall for Product Correction
Recall Action Instructions Philips Healthcare is advising users to check the connection of the C-arm to the column to ensure the C-arm is parallel to the column in side view. If the C-arm is not parallel, do not use the system and contact Philips Healthcare. Philips Healthcare is inspecting all affected units and applying a safety label on affected systems. Local service manuals will be updated at each system site.
Contact Information 1800 251 400 - Phillips Customer Care Centre