Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura

FDA device recall Z-0676-2025 · posted 2024-12-12 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.

Action taken

Philips Medical Systems notified consignees on 11/11/2024 via letter. Consignees were instructed that affected systems may continue to be used in accordance with their Indications for Use and Instructions for Use (IFU), to keep the Urgent Medical Device Correction letter with the documentation of the system until Philips corrects the system, circulate this notice to all users of the system so that they are aware of the issue, and if you experience erratic movement of the C-arm and/or if you see a portion of black area on the X-ray image, please call your local Philips representative to report the event. Philips will contact all affected customers to arrange for a Field Service Engineer visit to install an updated Lifetime Extension Kit. Consignees were also instructed to notify customers if further distributed and inform Philips about the transfer through the email account: IGT_Recalls@philips.com. Philips requested consignees complete and return the provided response form. On 11/24/2025, Philips sent a follow up letter to consignees to provide an update to the Urgent Medical Device Correction (MDC) issued on 11/11/2024. The updated letter informed consignees that after further technical investigation on both the hydrogen embrittlement and fatigue conditions, Philips has confirmed that these failure mechanisms do not apply to the bolts in question. Therefore, replacement is not required, even after 10 years of use. As a result, the risks and actions outlined in the original MDC no longer apply to affected systems.

Root cause

Equipment maintenance

Status

Open, Classified

Product code

OWB

Quantity affected

2,782 units

Distribution

Nationwide distribution. International distribution to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombi

Date initiated

2024-11-11

Date posted

2024-12-12

Location

Best, Netherlands

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