Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:29777
Brand Name:Mobile Digital X Ray System
Model:MobileDiagnost wDR 2.2 - model number 712006
Affected:
Software version:
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Philips Medical Systems DMC GmbH
Brand Name:Mobile Digital X Ray System
Model:MobileDiagnost wDR with Windows 10 Upgrade. Model Number: 712002
Affected:
Software version:2.2
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Philips Medical Systems DMC GmbH
Issue:The manufacturer has become aware of an anomaly with the Philips Mobile Diagnost wDR 2.2 that if a single fault condition such as earth/ground connection failure occurs while taking an exposure with a Mobile Diagnost wDR 2.2 connected to mains power, the leakage current (touch current) will exceed the 500 µA permitted under standard AS/NZ 3551 2012 Appendix B - Electrical Safety Testing (SECTION B10). However, the MobileDiagnost wDR 2.2 meets the touch current limit of 2000µA according to international safety standard IEC 60601-1 along with its particular and collateral standard requirements.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:1/3/2023
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