Data Foundry

Medical device recalls 2020

MultiDiagnost Eleva — Class II medical device recall Z-1489-2020

Terminated recall by Philips North America, LLC, reported 2020-03-25, distributed nationwide. A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a sh

Recall numberZ-1489-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips North America, LLC, Andover, MA, United States
Recall initiated2019-12-30
Classified2020-03-13
Reported by FDA2020-03-25
Terminated2022-11-17
DistributedNationwide (US)
Quantity534
Reason classesdevice malfunction
Serial numbers01H034592, 01H042957/78, 01H044355, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121 and 155 more

Product

MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038

Reason for recall

A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.

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-1489-2020. 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.