Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-0559-2024

Z-0559-2024 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best, N/A

Recall Details

Product Type
Devices
Report Date
December 27, 2023
Initiation Date
November 3, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3821 units

Product Description

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

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

Distribution Pattern

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.

Code Information

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).

Other recalls by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  • Z-1805-2026 Class II — Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medic (March 19, 2026)
  • Z-1692-2026 Class II — Vue Motion V12. Product Number: 1017979. (March 5, 2026)
  • Z-1678-2026 Class II — Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only (March 3, 2026)
  • Z-1672-2026 Class II — Allura Xper FD20/15 OR Table; System Code: 722059; (March 3, 2026)
  • Z-1666-2026 Class II — ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; (March 3, 2026)
  • Z-1664-2026 Class II — ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; (March 3, 2026)
  • Z-1668-2026 Class II — Allura Xper FD20/10; System Code: 722029; (March 3, 2026)
  • Z-1660-2026 Class II — ALLURA Xper FD10F; System Code: 722002; (March 3, 2026)
  • Z-1673-2026 Class II — Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; (March 3, 2026)
  • Z-1679-2026 Class II — Azurion 5 M12; System Code: (1)722227, (2)722231; (March 3, 2026)