Z-2716-2024Class II

Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers...

Name: Z-2716-2024 Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers...
Creator: Philips Medical Systems Nederland B.v.
Published: 2024-08-08
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2024-08-08 / Open, Classified

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013 on 2024-08-08. FDA classified it as Class II and gives the reason as "A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2716-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-08
Posted: 2024-08-22
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
FDA root cause: Under Investigation by firm
Action: An URGENT Medical Device Correction notification letter dated 7/31/24 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients. a. Affected systems may continue to be used in accordance with the Instructions for Use (IFU). b. 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. c. Circulate this notice to all users of the system so that they are aware of the issue. d. Should you experience uncontrolled C-arm movement, call your local Philips representative to report the event. e. Return the attached response form to Philips promptly and no later than 30 days from receipt to confirm that the users of the system have reviewed and understood this Medical Device Correction and required actions to be taken. Actions planned by Philips IGT-S to correct the problem Philips will contact all affected customers to arrange for a Field Service Engineer visit to install an updated Lifetime Extension Kit with the correct full-threaded bolt (reference FCO72200590). If you need any further information or support concerning this issue, contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).
Quantity in commerce: 6 units
Distribution: Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.
Product codes and lots: Serial Numbers: 111 138 467 817 2928 269

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2716-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2716-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-22

Product code OWB

K161563Class IIAllura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. / cleared 2016-07-29

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)