Z-2134-2025Class II

Azurion 7 M20. Fluoroscopic X-Ray System

Name: Z-2134-2025 Azurion 7 M20. Fluoroscopic X-Ray System
Creator: Philips Medical Systems Nederland B.v.
Published: 2025-06-04
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2025-06-04 / Open, Classified / root cause: design

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Azurion 7 M20. Fluoroscopic X-Ray System on 2025-06-04. FDA classified it as Class II and gives the reason as "Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose". 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-2134-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-04
Posted: 2025-07-18
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Azurion 7 M20. Fluoroscopic X-Ray System.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Root cause tag: design
FDA root cause: Device Design
Action: A "Device URGENT Medical Device Correction" notification dated 6/03/2025 was mailed to consignees. Consignees are instructed to circulate the provided notification to all system users and keep a copy of the recall notification with affected devices to maintain awareness. If you notice unusual noise during C-arm roll motion, or if the C-arm roll motion is disabled and the user message Motorized movement is not available appears, immediately contact a Philips representative. Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. Affected systems may continue to be used in accordance with their Instructions for Use (IFU). Complete and return the response form included in this Urgent Medical Device letter. Consignees are provided instructions to avoid rapidly pressing and releasing footswitch pedals and how to restart systems that experience the failure mode. The firm will deploy a software update in all affected system by June 2025. Consignees with any questions should contact their local Philips representative at 1-800-722-9377.
Quantity in commerce: 78 units
Distribution: 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).
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2134-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2134-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-18

Product code OWB

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)