CLASS II ONGOING Device recall · Reported 16 Mar 2022 · FDA Enforcement Report

Philips Allura CV20 Interventional Fluoroscopic X-ray recalled

Philips North America is recalling Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird, distributed nationwide in the US. The recall was initiated on 24 Nov 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesS/N: OUS 109

Quantity recalled1 unit

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-0725-2022
FDA event ID: 89375
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Nov 2021
FDA classified: 4 Mar 2022
Reported: 16 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

24 Nov 2021	Recall initiated by company
4 Mar 2022	Classified by FDA	+100 days
16 Mar 2022	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

Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031

Where it was distributed

US Nationwide Foreign: Argentina Austria Bangladesh Brazil Chile China Denmark Dominican Republic France Germany Greece India Indonesia Iran Israel Italy Japan Korea, Republic of Malaysia Mexico Netherlands Philippines Russian Federation Saudi Arabia South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey United Kingdom Virgin Islands (U.S.)

Nationwide

Questions about this recall

Is Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird recalled?

Yes. Philips North America recalled Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird on 24 Nov 2021. The recall is Class II and its status is Ongoing. Recall number Z-0725-2022.

Why was it recalled?

Which lots are affected?

S/N: OUS 109

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 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.

More recalls from Philips North America

All 531

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled	Philips North America	Device Malfunction	MA
26 Aug 2026Device	CLASS II	Cardiac Workstation recalled by Philips North America	Philips North America	Labeling Errors	Nationwide

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled	Canon Medical System, USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Lead & Heavy Metals