Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:19424
Brand Name:Philips Allura Xper FD and Allura Clarity x-ray systems
Model:722003, 722005, 722006, 722008, 722010, 722012, 722013, 722015, 722023, 722026, 722028, 722035, 722058
Affected:
Software version:All (upgrades to) Allura XPER or AlluraClarity with software releases 1.2.7, or 2.0.6, or 7.2.x where x<8 or 7.6.x or 7.8.x or 8.1.x where x< 16 or 8.2.x where x<16
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 Nederland BV
Issue:In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound, as is required in 21CFR1020.32 (h)(2)(ii) and IEC 60601-2-54, clause 203.6.2.1.c. No injuries attributed to the problem are reported.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:23/11/2015
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