Azurion FlexArm — Class II medical device recall Z-1130-2019
Terminated recall by Philips North America, LLC, reported 2019-04-17, distributed in FL. During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to speci
| Recall number | Z-1130-2019 |
|---|---|
| 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 | 2019-03-12 |
| Classified | 2019-04-11 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2020-10-07 |
| Distributed | FL |
| Countries outside the US | DE |
| Quantity | 2 |
| Serial numbers | 637, 638 |
Product
Azurion FlexArm, 722079
Reason for recall
During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.
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-1130-2019. 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.