Z-1066-2016Class II

Philips X-Ray Systems, Allura Xper with R8.2.16

Name: Z-1066-2016 Philips X-Ray Systems, Allura Xper with R8.2.16
Creator: Philips Electronics North America Corporation
Published: 2015-10-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-10-01 / Terminated / root cause: software

FDA source

Philips Electronics North America Corporation began a recall of Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular... on 2015-10-01. FDA classified it as Class II and gives the reason as "Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed". 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-1066-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-01
Posted: 2016-03-07
Terminated: 2020-10-08
Recalling firm: Philips North America LLC
Product: Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in 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 FD2O, Allura Xper FD2O/10 and Allura Xper FD2O/20 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
Root cause tag: software
FDA root cause: Software design
Action: Philips sent a Field Safety Notice to all affected customers on October 1, 2015. The notice informs customers of the issue and the actions planned by Philips. Philips Field Service Engineers are to install Software R8.2.16.1 which addresses the issue. For further information or support concerning the issue, consignees should contact their local Philips Representative or call the Technical Support Line at 800-722-9377.
Quantity in commerce: 196 devices
Distribution: US Nationwide in the states of : AK, AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, UT, WI, WV and the country of Canada.
Product codes and lots: Product Codes: 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059 systems with release R8.2.16

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1066-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1066-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-07

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)