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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01124-1
Product Name/Description Allura Xper, Allura Clarity & Integris

Multiple Product names affected

Allura System product codes
722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722034, 722035, 722038, 722039, 722058, 722400.

Integris product codes
72238, 72239, 72240, 72241, 72242, 72243 ,72244, 72245, 72246, 72247, 72248, 72249, 722021, 722030, 722043, 722044

ARTG # 175708, 98560
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 17/11/2015
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue The user may misinterpret still images as live images under following circumstances:

1. If while performing fluoroscopy, the user also depresses the single shot exposure pedal, resulting in a single shot still image being acquired and displayed on the screen. The live fluoroscopy is not resumed until the single-shot exposure pedal is released.

2. On systems with multiple fluoroscopy pedals and modes (such as biplane systems), if while fluoroscopy is active in one mode, the user also depresses a second fluoroscopy pedal for a different mode and then releases the first fluoroscopy pedal, the system will stop live imaging and display a still last image hold ) image.Then the device ignores the second pedal until both fluoroscopy pedals have been released.

Mistakenly interpreting still images as live images during interventional or diagnostic procedures can lead to unintended positioning of interventional and diagnostic devices and potentially resulting in patient injury or death.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is advising the users to follow the instructions given in the customer letter and the IFU when operating the device as follows:

- Be aware of the indicators related to X-ray on as described in the Instructions for Use (IFU).
- Be aware that it is not possible to perform fluoroscopy and exposure at the same time.
- USE ONLY ONE PEDAL at a time for image acquisition OR live imaging.
- Be aware that pressing a single shot exposure pedal results in a still exposure image being displayed. No new image is acquired as long as the single shot exposure pedal remains pressed.
- Always release the activated x-ray pedal after completion of image acquisition.
- Philips recommends the usage of an audible signal (X-ray buzzer) during live imaging. If your X-ray buzzer has been disabled, contact Philips if you decide to enable it as an additional safety precaution.

Philips is working with the TGA to determine whether any further risk mitigation actions are required. This action has been closed-out on 04/05/2017.
Contact Information 1800 251 400 - Philips Customer Care Centre