Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-1077-2025

Z-1077-2025 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best

Recall Details

Product Type
Devices
Report Date
February 12, 2025
Initiation Date
January 13, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
474 units US; 1908 units OUS

Product Description

Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026

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

Distribution Pattern

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.

Code Information

UDI: (1) 722003 00884838059191(10); (2) 722010 00884838059030(21); (3)722026 00884838054189(21).

Other recalls by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  • Z-2170-2026 Class II — Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, (March 31, 2026)
  • 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-1663-2026 Class II — ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; (March 3, 2026)
  • Z-1675-2026 Class II — Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; (March 3, 2026)
  • Z-1661-2026 Class II — ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; (March 3, 2026)
  • Z-1664-2026 Class II — ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; (March 3, 2026)
  • Z-1659-2026 Class II — Allura Xper FD10C; System Code: 722001; (March 3, 2026)
  • Z-1662-2026 Class II — ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; (March 3, 2026)
  • Z-1673-2026 Class II — Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; (March 3, 2026)