Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector — Class II medical device recall Z-1140-2019
Terminated recall by Philips Medical Systems Nederlands, reported 2019-04-24, distributed nationwide. Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequent
| Recall number | Z-1140-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems Nederlands, Best, N/A, Netherlands |
| Recall initiated | 2019-02-19 |
| Classified | 2019-04-13 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-10-14 |
| Distributed | Nationwide (US) |
| Quantity | 7,209 total |
| UPC / GTIN / UDI-DI | 00452270000141, 00459800415581 |
Product
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
Reason for recall
Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.
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-1140-2019. 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.