Device recall: Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, N/A, Netherlands.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

Device events that started in 2025

945

Share of these events in Class I

13%

Product records in this event

20Median of the firm: 1

Events of the firm on the register

59

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: all 59 events

• FDA enforcement report Z-1142-2025The FDA record of the first product of this event.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Where was the product distributed?

The FDA record gives this distribution: Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia…

What quantity of product is in FDA event 96132?

The event has 20 product records. The first record gives this quantity: 2,274 units (459 US, 1815 OUS)

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many device recalls of 2025 have the same class?

13% of the 945 device events that started in 2025 are in Class I.