Z-1589-2018Class II

Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional...

Name: Z-1589-2018 Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional...
Creator: Philips Electronics North America Corporation
Published: 2018-03-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-03-14 / Terminated / root cause: software

FDA source

Philips Electronics North America Corporation began a recall of Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper... on 2018-03-14. FDA classified it as Class II and gives the reason as "After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself". 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-1589-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-14
Posted: 2018-05-01
Terminated: 2024-04-29
Recalling firm: Philips North America LLC
Product: Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED 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, eg peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placement, embolization and thrombolysis. Cardiac imaging applications including diagnostics, interventional minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper ED series is compatible with a hybrid operating room.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself.
Root cause tag: software
FDA root cause: Software design
Action: Field Safety Notices were distributed on 3/14/18. The notices instructed customers: To prevent occurrence of the issue customers shall restart the system at least once a day. Customer shall ensure that all staff with access to the affected systems are informed of the contents of this Field Safety Notice. A copy of this Field Safety Notice shall be placed together with the documentation of the system until the system has been corrected by Philips. The problems will be resolved by a software update, which is expected to be available by the second half of 2018. You will be notified by your local Philips representative when the software update is available for installation. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377, 8am to 8pm (EST) Monday thru Friday.
Quantity in commerce: 682
Distribution: Worldwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The product was distributed to the following countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Cuba, Czech Republic, Denmark, Estonia, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Republic of Korea, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Caledonia, Norway, Pakistan, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and United Kingdom.
Product codes and lots: Product name: Allura Xper R8.1 .25.0 Allura Xper R8.1 .25.1 Allura Xper R8.1 .25.5 Allura Xper R8.2.25.0 Allura Xper R8.2.25.5 Allura Xper R8.2.27 UNIQ Ri .0.10 UNIQ Ri .0.10.5 Product code: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 7322039, 722058, 722059.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1589-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1589-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-01

Product code OWB

K133292Class IIAllura Xper Fd; or TablePhilips Medical Systems Nederland B.V. / cleared 2014-03-05

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)