Z-2498-2018Class II

Allura Xper

Name: Z-2498-2018 Allura Xper
Creator: Philips Healthcare
Published: 2018-06-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-06-11 / Terminated / root cause: software

FDA source

Philips Healthcare began a recall of Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive... on 2018-06-11. FDA classified it as Class II and gives the reason as "The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the...". 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-2498-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-11
Posted: 2018-07-25
Terminated: 2024-07-03
Recalling firm: Philips North America LLC
Product: Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Medical Device Correction letter dated June 11, 2018 was sent to customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers, until a software revision that corrects this issue becomes available, users should verify that the desired shutter position is set when performing the run after the first time the procedure type is changed during a single examination. This can be accomplished by first selecting a different procedure and then reselect the original procedure on the Xper Module or on the Data Monitor. 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. For questions contact your local Philips representative Technical Support Line 1-800-722-9377.
Quantity in commerce: 459 affected systems
Distribution: US Nationwide Distribution
Product codes and lots: Allura 8.1.25 Allura 8.1.25.1 Allura 8.1.25.5 Allura 8.2.25 Allura 8.2.25.5 Allura 8.2.27

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2498-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2498-2018	Class II	Terminated	FDA Mandated	2018-08-01	2018-07-24
Z-2499-2018	Class II	Terminated	FDA Mandated	2018-08-01	2018-07-24
Z-2500-2018	Class II	Terminated	FDA Mandated	2018-08-01	2018-07-24

Product code OWB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)