CLASS II ONGOING Device recall · Reported 30 Jul 2025 · FDA Enforcement Report
Azurion 7 M20 recalled by Philips Medical Systems
Philips Medical Systems Nederl is recalling Azurion 7 M20, distributed nationwide in the US. The recall was initiated on 4 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2134-2025
- FDA event ID
- 97055
- Recalling firm
- Philips Medical Systems Nederl, Best, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Jun 2025
- FDA classified
- 18 Jul 2025
- Reported
- 30 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 4 Jun 2025 | Recall initiated by company | |
| 18 Jul 2025 | Classified by FDA | +44 days |
| 30 Jul 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Product as listed by the FDA
Azurion 7 M20. Fluoroscopic X-Ray System.
Where it was distributed
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).
Nationwide ArkansasCaliforniaColoradoDistrict of ColumbiaDelawareFloridaIllinoisIndianaKentuckyMassachusettsMarylandMinnesotaMissouriMontanaNew JerseyNevadaNew YorkOhioSouth CarolinaTexas
Questions about this recall
Why was it recalled?
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Which lots are affected?
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.
Where was it sold?
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).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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