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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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.
See all 2 products in this recall →Related recalls
Same manufacturer · GE Healthcare, LLC
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
- HighGE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
- SevereGE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateGE Healthcare Recalls Senographe Essential Mammography Systems Due to Manual Defect
FDA (Devices) · 2013-07-03
- LowMammography systems recalled over a missing or incorrect X-ray warning label
FDA (Devices) · 2025-12-17
- HighSenographe Pristina X-ray system missing audible exposure termination signal
FDA (Devices) · 2024-02-14
- HighGE Healthcare Recalls Discovery IGS 730 Systems Due to Gantry Motion Loss
FDA (Devices) · 2015-07-08
- HighGE Healthcare Discovery IGS 730 Recalled for Potential Image Loss
FDA (Devices) · 2016-06-01
- HighGE Healthcare Discovery IGS 740 Systems Recalled for Image Loss
FDA (Devices) · 2016-06-01