GE Healthcare Lightspeed RT16 X-ray system — Class II medical device recall Z-2189-2017
Terminated recall by GE Healthcare, LLC, reported 2017-06-21, distributed nationwide. It was discovered that an issue has been identified that can result in a scan starting before the prescribed d
| Recall number | Z-2189-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2017-05-19 |
| Classified | 2017-06-12 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2018-07-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CH, ES, GB, JO, JP, KR, KW, LB, LT, LV, MA, MT, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VE, ZA |
| Quantity | 10,884 |
Product
GE Healthcare Lightspeed RT16 X-ray system
Reason for recall
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
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-2189-2017. 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.