Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-2134-2025

Z-2134-2025 Class II Ongoing

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

FDA device recall Z-2134-2025 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on June 4, 2025 and is designated Class II. Reason for recall: Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. The recall status is ongoing. Affected quantity: 78 units.

Recall Details

Product Type: Devices
Report Date: July 30, 2025
Initiation Date: June 4, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 78 units

Product Description

Azurion 7 M20. Fluoroscopic X-Ray System.

Reason for Recall

Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

Distribution Pattern

Worldwide distribution: US (nationwide) to states of: CA, CO, DC, DE, FL, IL, IN, KY, MA, MD, MN, MO, MT, NJ, NV, NY, OH, SC, TX, WA; and OUS (Foreign) to countries of: Argentina (AR), Australia (AU), Canada (CA), Chile (CL), Germany (DE), Dominican Republic (DO), Egypt (EG), ES, France (FR), United Kingdom (GB), Italy (IT), Japan (JP), Korea, Republic (KR), Mexico (MX), Netherlands (NL), New Zealand (NZ), Oman (OM), Reunion (RE), Saudi Arabi (SA), Thailand (TH), Viet Nam (VN).

Code Information

System Model No. 722079; UDI: 00884838085268; Serial No. 525, 584, 587, 613, 631, 658, 708, 774, 777, 793, 800, 801, 838, 842, 843, 862, 865, 866, 879, 881, 896, 899, 900, 905, 908, 909, 912, 915, 923, 925, 930, 939, 948, 955, 957, 992, 750, 814, 321, 370, 549, 567, 670, 687, 688, 693, 707, 743, 759, 767, 768, 775, 785, 786, 791, 819, 855, 871, 872, 902, 916, 917, 933, 936, 956, 960, 963, 965, 966, 969, 977, 993.

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)