Z-0559-2024Class II

Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223...

Name: Z-0559-2024 Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223...
Creator: Philips Medical Systems Nederland B.v.
Published: 2023-11-03
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2023-11-03 / Open, Classified / root cause: design

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion... on 2023-11-03. FDA classified it as Class II and gives the reason as "Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or...". 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-0559-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-03
Posted: 2023-12-15
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose
Root cause tag: design
FDA root cause: Device Design
Action: Philips issued Urgent Medical Device Correction (UMDC) letter US customers in the US on 11/3/23 and a Field Safety Notice (FSN) to customers outside the US. Letter states reason for recall, health risk and action to take: As a remedy, Philips is replacing the existing covers of all the affected Philips Allura and Philips Azurion with the monoplane fixed ceiling mounted systems with a redesigned L-arm rotation cover (bolted instead of spring clips) to make sure it is resistant to external collisions. Philips will contact all affected customers to arrange for a Field Service Engineer visit to replace the Larm rotation cover free of charge (reference FCO72200510 for the Philips Allura systems including the Philips Poly G H5000, FCO72200511 for the Philips Azurion systems). If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in commerce: 3821 units
Distribution: Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, CANADA, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Latvia, Latvia, Republic of Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, 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, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen.
Product codes and lots: Mdoel/Product Name/UDI-DI: 722078 Azurion 7 M12 (01)00884838085251(21); 722079 Azurion 7 M20 (01)00884838085268(21); 722223 Azurion 7 M12 (01)00884838099241(21); 722224 Azurion 7 M20 (01)00884838099258(21); 722227 Azurion 5 M12 (01)00884838099227(21); 722228 Azurion 5 M20 (01)00884838099234(21).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0559-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0558-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-15
Z-0559-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-15

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)