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Terminated

Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.

FDA Recall Z-0716-2018 · Posted 2018-02-24

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeOWB
Date Initiated2018-01-04
Date Terminated2019-10-09
Product Quantity705

Reason for Recall

There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these products. Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may also generate a peculiar burning smell that may be noticed. In some instances this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality is reduced.

Firm Action

Customer Notification letter dated August 2017 were sent to affected customers. The letter identified affected product, problem and actions to be taken. The customer is requested to place this Field Safety Notice with the documentation of the system until this correction has been implemented. For questions contact your local Philips representative.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Nationwide; foreign distribution to Brazil, Germany, Iceland, Japan, Mexico, and (updated 6/25/18) Saudi Arabia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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