Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-1647-2023

Z-1647-2023 Class II Ongoing

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

FDA device recall Z-1647-2023 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on March 21, 2023 and is designated Class II. Reason for recall: Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure The recall status is ongoing. Affected quantity: USA: 1063 R.O.W. 2136.

Recall Details

Product Type
Devices
Report Date
June 7, 2023
Initiation Date
March 21, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
USA: 1063 R.O.W. 2136

Product Description

Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224

Reason for Recall

Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure

Distribution Pattern

Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador Egypt Estonia Finland France French Polynesia Germany Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Lithuania Macao Macedonia Malaysia Mexico Morocco Myanmar Nepal Netherlands New Zealand Nicaragua Nigeria Norway Oman Pakistan Palestine Palestine, State of Panama Peru Philippines Poland Portugal Puerto Rico Qatar Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan Ukraine United Kingdom Utd.Arab.Emir. Uzbekistan Vietnam Yemen

Code Information

UDI-DI: System product name Model number UDI (1)Azurion 3M12: 722063 (01)00884838085275(21) 722221 (01)00884838099203(21); (2) Azurion 3M15: 722064 (01)00884838085282(21) 722222 (01)00884838099210(21); (3) Azurion SM12: 722227 (01)00884838099227(21); (4) Azurion SM20: 722228 (01)00884838099234(21); (5) Azurion 7B12/12: 722067 (01)00884838085350(21) 722225 (01)00884838099265(21); (6) Azurion 7820/15: 722068 (01)00884838085367(21) 722226 (01)00884838099272(21); (7) Azurion 7M12: 722078 (01)00884838085251(21) 722223 (01)00884838099241(21); (8) Azurion 7M20: 722079 (01)00884838085268(21) 722224 (01)00884838099258(21), Software: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6

Other recalls by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  • Z-2932-2026 Class II — Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, (July 16, 2026)
  • Z-2931-2026 Class II — Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, (July 16, 2026)
  • Z-2928-2026 Class II — Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 7 (June 29, 2026)
  • Z-2893-2026 Class II — Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interve (June 17, 2026)
  • Z-2892-2026 Class II — Philips Azurion under the following System Descriptions and corresponding model (June 17, 2026)
  • Z-2891-2026 Class II — Philips Allura under the following System Descriptions and corresponding model n (June 17, 2026)
  • Z-2411-2026 Class II — Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 (May 18, 2026)
  • Z-2412-2026 Class II — Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura (May 18, 2026)
  • Z-2259-2026 Class II — Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003 (April 30, 2026)
  • Z-2258-2026 Class II — Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, (April 30, 2026)

FDA data resources