GE Healthcare Senographe Essential System — Class II medical device recall Z-1519-2013
Terminated recall by GE Healthcare, LLC, reported 2013-07-03, distributed nationwide. GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associa
| Recall number | Z-1519-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-01-14 |
| Classified | 2013-06-26 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2013-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 49 installed |
| Model numbers | 5144816-10, 5144816-10-LE, REV1 |
Product
GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems.
Reason for recall
GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual CD of the Senographe Essential.
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-1519-2013. 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.