CLASS II ONGOING Device recall · Reported 12 Feb 2025 · FDA Enforcement Report

Azurion 7 B20 System recalled by Philips Medical Systems

Philips Medical Systems Nederland B.v is recalling Azurion 7 B20 System, distributed nationwide in the US. The recall was initiated on 13 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (1) 722068 00884838085367(21); (2) 722226 00884838099272(21); (3) 722236 00884838116801(21)

Quantity recalled251 units US; 938 units OUS

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-1092-2025
FDA event ID: 96120
Recalling firm: Philips Medical Systems Nederland B.v, Best
Classification: Class II
Status: Ongoing
Recall initiated: 13 Jan 2025
FDA classified: 4 Feb 2025
Reported: 12 Feb 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Jan 2025	Recall initiated by company
4 Feb 2025	Classified by FDA	+22 days
12 Feb 2025	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

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

Product as listed by the FDA

Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

Nationwide Georgia

Questions about this recall

Is Azurion 7 B20 System recalled?

Yes. Philips Medical Systems Nederland B.v recalled Azurion 7 B20 System on 13 Jan 2025. The recall is Class II and its status is Ongoing. Recall number Z-1092-2025.

Why was it recalled?

Which lots are affected?

UDI: (1) 722068 00884838085367(21); (2) 722226 00884838099272(21); (3) 722236 00884838116801(21)

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 Medical Systems Nederland B.v

All 200

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Lead & Heavy Metals
19 Aug 2026Device	CLASS II	Allura Xper FD recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Other	Nationwide
12 Aug 2026Device	CLASS II	Philips Allura, Cardio Vascular-Allura Centron recalled	Philips Medical Systems Nederland B.v	Other	Nationwide
24 Jun 2026Device	CLASS II	Philips Allura Xper with the following recalled	Philips Medical Systems Nederland B.v	Other
24 Jun 2026Device	CLASS II	Philips MultiDiagnost Eleva with the following recalled	Philips Medical Systems Nederland B.v	Other

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide