Z-0716-2018Class II

Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage

Name: Z-0716-2018 Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage
Creator: Philips Electronics North America Corporation
Published: 2018-01-04
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-01-04 / Terminated / root cause: design

FDA source

Philips Electronics North America Corporation began a recall of 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 2018-01-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0716-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-04
Posted: 2018-02-24
Terminated: 2019-10-09
Recalling firm: Philips North America LLC
Product: 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.
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 705
Distribution: Worldwide Distribution - US Nationwide; foreign distribution to Brazil, Germany, Iceland, Japan, Mexico, and (updated 6/25/18) Saudi Arabia.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0716-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0716-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-24

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)