GE Healthcare recalls Pristina Serena breast biopsy accessories due to potential slippage during rotation. Affected units have specific serial numbers. Stop using immediately to prevent injury.
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
GE Healthcare recalls certain Pristina Serena breast biopsy accessories because they may slip during rotation. This could lead to injury during breast biopsy procedures if the device moves unexpectedly.
The biopsy positioner may slip when the imaging gantry rotates during a biopsy procedure. This could cause the device to move unexpectedly, potentially leading to injury.
Healthcare providers using the Pristina Serena accessory with Senographe Pristina breast imaging systems. Those performing breast biopsies are most at risk.
Check for the following serial numbers: 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4, and 732113BU6.
Verify your Pristina Serena accessory has one of the listed serial numbers: 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4, and 732113BU6.
If your accessory has a listed serial number, stop using it immediately to prevent potential injury during breast biopsies.
The Pristina Serena is an optional accessory for Senographe Pristina breast imaging systems that provides accurate 3D location of breast lesions.
The recall is due to potential slippage of the biopsy positioner when the imaging gantry rotates during a biopsy procedure, which could lead to injury.
Check the serial number on your device against the list: 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4, and 732113BU6.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2132-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2132-2019 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
