Phillips Azurion 7 M20 — Class II medical device recall Z-1801-2020
Terminated recall by Philips North America, LLC, reported 2020-05-06, distributed nationwide. No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm
| Recall number | Z-1801-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2020-03-05 |
| Classified | 2020-04-24 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2022-09-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, CL, CZ, DE, DK, ES, FI, FR, HR, IL, IN, IT, JP, KR, LB, MX, NL, NO, PK, PL, SE, TW, UY, ZA |
| Quantity | 162 units |
| Serial numbers | 262, 263, 428, 429, 439, 466, 488, 497, 520, 526, 534, 535, 536, 540, 543, 588, 590, 594, 595, 598, 605, 608, 611, 618, 621 and 56 more |
Product
Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
Reason for recall
No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose..
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1801-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.