CLASS II Device recall · Reported 6 May 2020 · FDA Enforcement Report

Philips Azurion 7 M20 -XperGuide recalled by Philips North America

Philips North America is recalling Philips Azurion 7 M20 -XperGuide, distributed in Florida, Idaho, Illinois, Indiana, Massachusetts, Ohio. The recall was initiated on 3 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware:Philips Azurion 2.0 Interventional Fluoroscopic X-ray system with Interventional Workspot 1.5 US Serial Numbers: 637, 200, 909, 1276, 1309, 987 Canada: 1016 ROW: 11169 1129 1143 971 1135 824 934 1089 1008 1165 1080 1019 1248 523 1172 Expanded Recall OUS: 1223, 1330, 703424

Quantity recalled22 units (6 US and 16 OUS); Expanded 3units; Total: 25

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-1809-2020
FDA event ID: 85399
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 3 Apr 2020
FDA classified: 29 Apr 2020
Reported: 6 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

3 Apr 2020	Recall initiated by company
29 Apr 2020	Classified by FDA	+26 days
6 May 2020	Published in enforcement report	+7 days

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

Reason for recall

When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path.

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

Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079

Where it was distributed

Worldwide distribution. US states of FL, ID, IL, IN, MA, and OH, Canada, Australia, Austria, Belgium, Germany, and Netherlands New Zealand, South Africa, Switzerland, Thailand

Florida Idaho Illinois Indiana Massachusetts Ohio

Questions about this recall

Is Philips Azurion 7 M20 -XperGuide recalled?

Yes. Philips North America recalled Philips Azurion 7 M20 -XperGuide on 3 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-1809-2020.

Why was it recalled?

Which lots are affected?

Software:Philips Azurion 2.0 Interventional Fluoroscopic X-ray system with Interventional Workspot 1.5 US Serial Numbers: 637, 200, 909, 1276, 1309, 987 Canada: 1016 ROW: 11169 1129 1143 971 1135 824 934 1089 1008 1165 1080 1019 1248 523 1172 Expanded Recall OUS: 1223, 1330, 703424

Where was it sold?

Worldwide distribution. US states of FL, ID, IL, IN, MA, and OH, Canada, Australia, Austria, Belgium, Germany, and Netherlands New Zealand, South Africa, Switzerland, Thailand

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

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