FDA Device recall Z-2132-2019
GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location o…
- FDA Device
- Class II
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location o… by Ge Healthcare, citing potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2132-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-16 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.
Reason
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
Identifiers
| code_info | Serial# 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 7…Serial# 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4 and 732113BU6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2132-2019%22
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