Z-2534-2024Class II

Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2...

Name: Z-2534-2024 Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2...
Creator: Philips Medical Systems Nederland B.v.
Published: 2024-07-15
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2024-07-15 / Open, Classified / root cause: design

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic... on 2024-07-15. FDA classified it as Class II and gives the reason as "Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2534-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-15
Posted: 2024-08-08
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedure. Model Numbers: 722063, 722064, 722067, 722068, 722078 and 722079
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
Root cause tag: design
FDA root cause: Device Design
Action: Philips issued URGENT Medical Device Correction Letter to US consignees on July 15th, 2024, via certified mail. Letter states reason for recall, health risk and action to take: Circulate this Urgent Medical Device Correction to all users of the system so that they are aware of the issue. " Keep this Urgent Medical Device Correction with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. " Should you experience a loss of imaging (X-ray) functionality or a prolonged system restart time, call your local Philips representative to report the event. " Complete and return the attached response form (page 4) to Philips promptly and no later than 30 days from receipt. This confirms that the users of the system have reviewed and understand this Urgent Medical Device Correction and required actions to be taken. Philips is working on a software release (R2.2.10) that will correct these two issues (ref. FCOs: FCO72200548, FCO72200580, FCO72200582, FCO72200583, FCO72200584, FCO72200592). For those systems that have an Interventional Workspot (IW) and/or EchoNavigator, Philips will upgrade the software version of the IW and/or EchoNavigator to maintain compatibility with the updated Philips Azurion system software (R2.2.10). Your local Philips representative will contact you to schedule a visit to install the software update once available. Philips expects this software to be released by Q1 2025. If you need additional information or support concerning these issues, contact your local Philips representative at 1-800- 722-9377 (Philips Customer Care Solutions Center).
Quantity in commerce: 3011 units
Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan Palestine, State of Peru, Philippines, Poland, Portugal, R¿union Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.
Product codes and lots: Model /UDI-DI: (1) 722063 (01)00884838085275(21); (2) 722064 (01)00884838085282(21); (3) 722067 (01)00884838085350(21); (4) 722068 (01)00884838085367(21); (5) 722078 (01)00884838085251(21); (6) 722079 (01)00884838085268(21). Software Version Number: R1.0, R1.1, R1.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2534-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2534-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-08

Product code OWB

K200917Class IIAzurion R2.1Philips Medical Systems Nederland B.V. / cleared 2020-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)