Z-1895-2024Class II

Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number...

Name: Z-1895-2024 Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number...
Creator: Philips Medical Systems Nederland B.v.
Published: 2024-05-16
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2024-05-16 / Open, Classified / root cause: software

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100 on 2024-05-16. FDA classified it as Class II and gives the reason as "When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1895-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-16
Posted: 2024-05-24
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: On May 14, 2024 URGENT Medical Device Correction letters were sent to consignees. Actions that should be taken by the customer / user to lower risks for patients: " Circulate this Urgent Medical Device Correction letter to all users so that they are aware of the issue. " Philips recommends discontinuing use of the system for procedures that can be safely postponed to another time, or for procedures that can be performed with another system. " Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure the letter is in a place likely to be seen/viewed. " Please complete and return the attached response form (on page 3) to Philips promptly and no later than 15 days from receipt. Completing this form confirms receipt of the Medical Device Correction letter and understanding of the issue and required actions to be taken. 5. Actions planned by Philips IGT-S to correct the issue: Philips will be re-installing the previous software release in all affected systems. Philips will contact affected customers immediately to schedule a visit to perform this software change (reference FCO72200588). If you need additional information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).
Quantity in commerce: 1 unit (US)
Distribution: Domestic: OK International: India, Spain, U.A.E.
Product codes and lots: Product number: 722012, UDI/DI: 00884838059054; Serial Number: 2138.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1895-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1895-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-24
Z-1896-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-24
Z-1897-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-24

Product code OWB

K162859Class IIAllura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. / cleared 2016-12-02

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)