Z-0717-2018Class II

Allura Xper FD and and Xper FD ORT - Philips X-ray Systems

Name: Z-0717-2018 Allura Xper FD and and Xper FD ORT - Philips X-ray Systems
Creator: Philips Electronics North America Corporation
Published: 2017-12-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-12-20 / Terminated / root cause: design

FDA source

Philips Electronics North America Corporation began a recall of Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and... on 2017-12-20. FDA classified it as Class II and gives the reason as "Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the two gliding rods into an aluminum block of...". 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-0717-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-20
Posted: 2018-02-24
Terminated: 2020-06-16
Recalling firm: Philips North America LLC
Product: Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/15 and Allura Xper FD10/10 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology. Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper FD series is compatible with a hybrid Operating Room (OR Table)
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the two gliding rods into an aluminum block of the support arm can come loose because of vibrations and forces exerted on them. If the set screws have come loose gravity can keep the rods in position. However, if a force is exerted on the monitor pushing it forward, the monitor can topple forward. Once the monitor has toppled over it is only attached with its wires. If the monitor breaks loose of its wires it will drop on the floor.
Root cause tag: design
FDA root cause: Device Design
Action: Philips sent an Urgent Field Safety Notice letter December 20, 2017 dated to all affected customers. The letter identified the affected product, problem and the actions to be taken. For question contact your local Philips representative.
Quantity in commerce: 1486
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: All Allura Xper FD and and Xper FD ORT manufactured from July 2003 - May 2017 with system Codes: 722001 722002 722003 722010 722026 722005 722011 722027 722006 722012 722028 722008 722013 722015 722023 722035 722020 722029 722038 722039 722058 722059

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0717-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0717-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-24

Product code OWB

K141979Class IIAllura Xper Fd Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV / cleared 2014-08-19

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)