CLASS II Device recall · Reported 9 Dec 2015 · FDA Enforcement Report

Philips Healthcare Allure BiPlane Series recalled

Philips Medical Systems is recalling Philips Healthcare Allure BiPlane Series, distributed nationwide in the US. The recall was initiated on 3 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSystem : S/N : Model: 722013 262 Allura Xper FD20 BIPLANE R7.6 722013 422 Allura Xper FD20 BIPLANE R7.7 722013 195 Allura Xper FD20 BIPLANE R7.8 722013 173 Allura Xper FD20 BIPLANE R7.9 722013 225 Allura Xper FD20 BIPLANE R7.10

Quantity recalled5 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-0347-2016
FDA event ID: 70370
Recalling firm: Philips Medical Systems, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 3 Feb 2015
FDA classified: 30 Nov 2015
Reported: 9 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Pacemakers & Defibrillators

Timeline

3 Feb 2015	Recall initiated by company
30 Nov 2015	Classified by FDA	+300 days
9 Dec 2015	Published in enforcement report	+9 days

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

Reason for recall

Monitor Ceiling Suspension system may fall

Product as listed by the FDA

Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xper FD20 BIPLANE R7.8 722013 Allura Xper FD20 BIPLANE R7.9 722013 Allura Xper FD20 BIPLANE R7.10 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures

Where it was distributed

Worldwide Distribution - US Nationwide and the countries of: Canada,Australia, Austria, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, South Africa, Spain, Switzerland and United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Monitor Ceiling Suspension system may fall

Which lots are affected?

System : S/N : Model: 722013 262 Allura Xper FD20 BIPLANE R7.6 722013 422 Allura Xper FD20 BIPLANE R7.7 722013 195 Allura Xper FD20 BIPLANE R7.8 722013 173 Allura Xper FD20 BIPLANE R7.9 722013 225 Allura Xper FD20 BIPLANE R7.10

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

8 other products · FDA event 70370

This product is part of a recall event; the main page for the event is Philips Healthcare Integris vascular System recalled.

Reported	Class	Recall	Company	Reason	Where
9 Dec 2015	CLASS II	Philips Healthcare Integris vascular System recalled	Philips Medical Systems	Other	Nationwide
9 Dec 2015	CLASS II	Philips Healthcare Xper vascular systems R7.6 recalled	Philips Medical Systems	Other	Nationwide
9 Dec 2015	CLASS II	Philips Healthcare Integris H5000F/Allura 9F recalled	Philips Medical Systems	Other	Nationwide
9 Dec 2015	CLASS II	Philips Healthcare Allura Xper Series recalled	Philips Medical Systems	Other	Nationwide
9 Dec 2015	CLASS II	Philips Healthcare Integris cardio system recalled	Philips Medical Systems	Other	Nationwide
9 Dec 2015	CLASS II	Philips Healthcare Xper vascular system recalled	Philips Medical Systems	Other	Nationwide
9 Dec 2015	CLASS II	Philips Healthcare Xper cardio systems R7.6 recalled	Philips Medical Systems	Other	Nationwide
9 Dec 2015	CLASS II	Philips Healthcare Xper cardio systems recalled	Philips Medical Systems	Other	Nationwide

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