CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report

Allura Xper FD10 recalled by Philips Medical Systems

Philips Medical Systems Nederl is recalling Allura Xper FD10, distributed nationwide in the US. The recall was initiated on 15 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 722026; System Product Name: Allura Xper FD10; UDI-DI: 00884838054189; Serial Numbers: 969, 223, 648, 664, 622, 931, 128, 616, 497, 769, 143, 881, 809, 18, 326, 794, 174, 804, 424, 587, 172, 911, 294, 569, 141, 161, 182, 928, 960, 858, 494, 628, 749, 968, 17, 273, 43, 203, 546, 104, 430, 575, 180, 594, 359, 723, 779, 632, 183, 330, 726, 637, 300, 429, 810, 995, 293, 296, 573, 917, 695, 676, 913, 274, 734, 520, 27, 940, 597, 598, 301, 818, 916, 328, 912, 691, 410, 873, 868, 816, 732, 147, 742, 651, 919, 89, 918, 346, 250, 755, 199, 255, 524, 256, 623;

Quantity recalled95 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1073-2026
FDA event ID: 98109
Recalling firm: Philips Medical Systems Nederl, Best
Classification: Class II
Status: Ongoing
Recall initiated: 15 Dec 2025
FDA classified: 13 Jan 2026
Reported: 21 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

15 Dec 2025	Recall initiated by company
13 Jan 2026	Classified by FDA	+29 days
21 Jan 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

Product as listed by the FDA

Allura Xper FD10; Model Number: 722026;

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Number: 722026; System Product Name: Allura Xper FD10; UDI-DI: 00884838054189; Serial Numbers: 969, 223, 648, 664, 622, 931, 128, 616, 497, 769, 143, 881, 809, 18, 326, 794, 174, 804, 424, 587, 172, 911, 294, 569, 141, 161, 182, 928, 960, 858, 494, 628, 749, 968, 17, 273, 43, 203, 546, 104, 430, 575, 180, 594, 359, 723, 779, 632, 183, 330, 726, 637, 300, 429, 810, 995, 293, 296, 573, 917, 695, 676, 913, 274, 734, 520, 27, 940, 597, 598, 301, 818, 916, 328, 912, 691, 410, 873, 868, 816, 732, 147, 742, 651, 919, 89, 918, 346, 250, 755, 199, 255, 524, 256, 623;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

15 other products · FDA event 98109

This product is part of a recall event; the main page for the event is Allura Xper FD10F recalled by Philips Medical Systems.

Reported	Class	Recall	Company	Reason	Where
21 Jan 2026	CLASS II	Allura Xper FD10F recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD10/10 recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD20 recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD10C recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD10 recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD10/10 recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD20/20 recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD10/10 recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD20 recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD20/10 recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD10 recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD20 Biplane recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD20 OR Table recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD20 Biplane recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
21 Jan 2026	CLASS II	Allura Xper FD20 recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide

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24 Jun 2026Device	CLASS II	Philips Allura Xper with the following recalled	Philips Medical Systems Nederl	Other
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