Z-0716-2018 Class II Terminated
FDA device recall Z-0716-2018 was initiated by Philips Electronics North America Corporation on Jan 4, 2018 and is designated Class II. 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… The recall status is terminated (terminated Oct 9, 2019). Affected quantity: 705.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 7, 2018
- Initiation Date
- Jan 4, 2018
- Termination Date
- Oct 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 705
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - US Nationwide; foreign distribution to Brazil, Germany, Iceland, Japan, Mexico, and (updated 6/25/18) Saudi Arabia.
Code Information
Allura Xper systems - Model #'s 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722078, 722079, (added as of 6/25/2018) 1120
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0716-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026