GE Senographe Pristina Mammography Systems Recalled for Biopsy Positioner Slippage
GE Healthcare is recalling 82 Senographe Pristina mammography systems because the biopsy positioner may slip when the gantry is rotated during a procedure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect that could compromise the accuracy of a biopsy procedure. This fits the rubric for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or illnesses are cited in the source text.
Plain-English summary
GE Healthcare, LLC is recalling 82 units of the GE Senographe Pristina digital mammography system. The recall is due to a potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. The Senographe Pristina is used to generate digital mammographic images for screening and diagnosis of breast cancer.
The affected units were distributed worldwide, including in the United States and various international countries. The recall covers specific serial numbers listed in the official FDA notice. No specific dates of distribution or installation are provided in the source text.
Healthcare facilities using these devices should contact GE Healthcare for instructions on how to address the issue. Patients who have undergone biopsy procedures on these specific units should consult their healthcare provider if they have concerns regarding the procedure.
The recalled product
- 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 mammograp
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 82
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial# 716784BU4
- 716785BU1
- 716786BU9
- 716787BU7
- 716788BU5
- 718583BU8
- 718584BU6
- 718585BU3
- 718586BU1
- 718587BU9
- 718588BU7
- 718589BU5
- 718591BU1
- 718592BU9
- 718593BU7
- 718594BU5
- 718595BU2
- 718596BU0
- 718597BU8
- 718598BU6
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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