Velara Generator with an old Firmware version used with the Philips… — Class II medical device recall Z-1062-2017
Terminated recall by Philips Electronics North America Corporation, reported 2017-02-01, distributed in AL, CA, DC, GA, IL, KS, MD, MO…. System may lock up.
| Recall number | Z-1062-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2016-12-09 |
| Classified | 2017-01-20 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2020-07-30 |
| Distributed | AL, CA, DC, GA, IL, KS, MD, MO, NC, NY, OH, PA, RI, SC, TX, WA |
| Countries outside the US | BG, BR, CH, CR, DE, ES, FR, GB, IL, IT, JP, KR, MX, SE, SG, TR |
| Quantity | 59 devices |
| UPC / GTIN / UDI-DI | 00989000070124 |
Product
Velara Generator with an old Firmware version used with the Philips Integris BH5000
Reason for recall
System may lock up.
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-1062-2017. 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.