CLASS II Device recall · Reported 7 Sep 2016 · FDA Enforcement Report

Allura Xper with release R8.2: Allura Xper FD10 recalled

Philips Electronics North America is recalling Allura Xper with release R8.2: Allura Xper FD10, 722026, distributed nationwide in the US. The recall was initiated on 7 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAllura Xper with release R8.2,

Quantity recalled1536 devices (includes both Allura and UNIQ)

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-2669-2016
FDA event ID: 74616
Recalling firm: Philips Electronics North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 7 Jul 2016
FDA classified: 26 Aug 2016
Reported: 7 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

7 Jul 2016	Recall initiated by company
26 Aug 2016	Classified by FDA	+50 days
7 Sep 2016	Published in enforcement report	+12 days

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

Reason for recall

Increase in the failure rate of certain low-voltage DC power supplies (DCPS)

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; Allura Xper FD20 OR Table, 722035; Allure Xper FD20/20 , 722038; Allura Xper FD20/20 biplane OR Table, 722039; Allura Xper FD20/15, 722058; Allura Xper FD20/15 OR Table, 722059

Where it was distributed

Nationwide, Canada, Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Bulgaria CHILE China Colombia Croatia Cuba Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Finland France French Polynesia Georgia Germany Greece Honduras Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Lebanon Lithuania Macedonia Malaysia Malta Mexico Morocco Myanmar Nepal Netherlands New Caledonia Norway Oman Pakistan Palestine, State of PERU Philippines Poland Portugal Qatar R¿union Romania RUSSIAN FEDERAT Russian Federation Saudi Arabia Singapore Slovakia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Tanzania Thailand Tunisia Turkey Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam

Nationwide Georgia

Questions about this recall

Why was it recalled?

Increase in the failure rate of certain low-voltage DC power supplies (DCPS)

Which lots are affected?

Allura Xper with release R8.2,

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

1 other product · FDA event 74616

This product is part of a recall event; the main page for the event is Uniq 1.0: Uniq Fd10 recalled by Philips Electronics North.

Reported	Class	Recall	Company	Reason	Where
7 Sep 2016	CLASS II	Uniq 1.0: Uniq Fd10 recalled by Philips Electronics North	Philips Electronics North America	Device Malfunction	Nationwide

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