GE Healthcare recalls specific models of Senographe Pristina mammography machines due to potential slippage of the biopsy positioner during rotation, which could lead to inaccurate procedures.
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
GE Healthcare is recalling certain models of Senographe Pristina mammography machines because the biopsy positioner might slip during rotation, potentially causing inaccurate procedures. This recall affects healthcare facilities using these machines for breast cancer screening and diagnosis.
During a biopsy procedure, the biopsy positioner might slip when the machine's gantry rotates. This slippage could lead to inaccurate biopsy results, potentially affecting diagnosis and treatment decisions.
Healthcare facilities that use the recalled Senographe Pristina machines for breast cancer screening and diagnosis are most at risk. Patients undergoing biopsies with these machines could experience inaccurate results.
Check the serial numbers listed in the recall notice: 716784BU4, 716785BU1, 716786BU9, and other specific serial numbers provided in the recall. These machines were sold between 2015 and 2020.
Verify if your machine has a serial number from the list provided in the recall notice.
Reach out to GE Healthcare for guidance on next steps if your machine is affected.
The biopsy positioner might slip when the machine's gantry rotates during a biopsy procedure, potentially leading to inaccurate results.
The affected serial numbers include 716784BU4, 716785BU1, 716786BU9, and other specific numbers listed in the recall notice.
No, the recall requires caution but does not mandate immediate discontinuation. Contact GE Healthcare for specific guidance.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2131-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2131-2019 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.
