Prestige SI — Class II medical device recall Z-0912-2017
Terminated recall by GE Healthcare, LLC, reported 2017-01-04, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, P
| Recall number | Z-0912-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2016-11-21 |
| Classified | 2016-12-23 |
| Reported by FDA | 2017-01-04 |
| Terminated | 2017-09-26 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA, WV, WY |
| Countries outside the US | AE, AT, AU, BR, CA, CL, CN, DE, DK, DZ, EG, ES, FR, GB, GT, HK, HN, HU, IE, IN, IS, IT, JP, KR, MX, NL, PE, PL, PT, RS, RU, SA, SK, TH, TR, TW, VE, VN |
Product
Prestige SI
Reason for recall
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
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-0912-2017. 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.