Philips Azurion 7 M20 Fluoroscopy System: Loose Bolts Risk
Philips recalls Azurion 7 M20 fluoroscopy systems with potential loose bolts connecting the C-arm gearbox to mounting flange. Affected units have specific serial numbers. No remedy stated in recall notice.
Recall notice
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Contact the company
What happened, in plain English
Philips is recalling Azurion 7 M20 fluoroscopy systems due to a risk that bolts connecting the C-arm gearbox to the mounting flange could become loose. This could potentially cause the system to malfunction or become unstable during use. Read more at govinfonow.com/recall/52152-philips-azurion-7-m20-fluoroscopy-system-loose-bolts-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/52152-philips-azurion-7-m20-fluoroscopy-system-loose-bolts-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2134-2025
Cite this page
“Philips Azurion 7 M20 Fluoroscopy System: Loose Bolts Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52152-philips-azurion-7-m20-fluoroscopy-system-loose-bolts-risk. Based on FDA recall #Z-2134-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2134-2025%22&limit=1).
Why it’s dangerous
The bolts connecting the C-arm gearbox to the mounting flange may become loose over time. This could cause the C-arm to move unexpectedly, potentially leading to system malfunction or instability during medical procedures.
Who’s affected
Medical facilities using Philips Azurion 7 M20 fluoroscopy systems are likely affected. Staff and patients using these systems could be at risk if the C-arm becomes unstable.
How to tell if you have this one
Check for serial numbers listed in the recall: 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.
- Brand
Philips- Category
Medical device
What to do — step by step
Check Serial Numbers
Review the serial numbers listed in the recall notice to determine if your system is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 19 states.
FDA 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),…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Delaware, District of Columbia, Florida, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Minnesota, Missouri, Montana, Nevada, New Jersey, New York, Ohio, South Carolina, Texas, Washington.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2134-2025 (June 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2134-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.