Philips Azurion 7 M20 -XperGuide Software hosted in Interventional… — Class II medical device recall Z-1809-2020
Terminated recall by Philips North America, LLC, reported 2020-05-06, distributed in FL, ID, IL, IN, MA, OH. When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-
| Recall number | Z-1809-2020 |
|---|---|
| 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 | 2020-04-03 |
| Classified | 2020-04-29 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2023-02-01 |
| Distributed | FL, ID, IL, IN, MA, OH |
| Countries outside the US | AT, AU, BE, CA, CH, DE, NL, NZ, TH, ZA |
| Reason classes | software |
| Serial numbers | 1276, 1309, 200, 637, 909, 987 |
Product
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
Reason for recall
When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path.
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-1809-2020. 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.