GE Senographe Pristina — Class II medical device recall Z-2131-2019
Terminated recall by GE Healthcare, LLC, reported 2019-08-07, distributed nationwide. Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
| Recall number | Z-2131-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-05-16 |
| Classified | 2019-07-30 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2020-12-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CL, CZ, DE, DZ, FI, FR, GB, HU, IS, JP, KR, KW, LB, LK, NO, NZ, PL, SA, SE, TH, TR, TW, VN, ZA |
| Quantity | 82 |
| Serial numbers | 716784BU4, 716785BU1, 716786BU9, 716787BU7, 716788BU5, 718583BU8, 718584BU6, 718585BU3, 718586BU1, 718587BU9, 718588BU7, 718589BU5, 718591BU1, 718592BU9, 718593BU7, 718594BU5, 718595BU2, 718596BU0, 718597BU8, 718598BU6, 718599BU4, 718600BU0, 718601BU8, 718602BU6, 722648BU3 and 54 more |
Product
GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based mammographic systems.
Reason for recall
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
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-2131-2019. 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.