Z-0181-2015Class II

Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code...

Name: Z-0181-2015 Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code...
Creator: Philips Medical Systems, Inc.
Published: 2014-07-08
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-07-08 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for... on 2014-07-08. FDA classified it as Class II and gives the reason as "Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0181-2015
Classification: Class II
Status: Terminated
Initiated: 2014-07-08
Posted: 2014-11-07
Terminated: 2017-01-18
Recalling firm: Philips North America LLC
Product: Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
Root cause tag: software
FDA root cause: Software design
Action: Philips Medical Systems issued certified letters on 7/8/14 and receipt returned for tracking purposes. A mandatory Field Change Order with reference FC072200253 is being released that requires Philips field service engineers to install Software release R8.2.0.3. If you need any further information or support concerning this issue, contact your local Philips representative: SUPPORT 1-800-722-9377.
Quantity in commerce: 22 systems
Distribution: Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam.
Product codes and lots: Allura Xper Software version: R8.2.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0181-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0181-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07
Z-0182-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07

Product code OWB

K033737Class IIAllura Xper Fd20Philips Medical Systems North America, Inc. / cleared 2003-12-09

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)