Reported Jul 30, 2025 · Ongoing
Azurion 7 M20. Fluoroscopic X-Ray System.
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best, N/A · N/A
Is this the product you have?
- Azurion 7 M20. Fluoroscopic X-Ray System.
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 722079System — 00884838085268UDI: 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. - Amount recalled
- 78 units
Where it was sold
Why it was recalled
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
This product could cause temporary or reversible health problems — stop using it.
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