Senographe Pristina recallZ-0862-2024 · GE Medical Systems, SCS · initiated Dec 26, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Medical Systems, SCS or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
GE HealthCare will, without charge, remedy the defect or bring the product into compliance. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall details
- Recall number
- Z-0862-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 26, 2023
- Posted by the FDA
- Feb 8, 2024
- Recalling firm
- GE Medical Systems, SCS
- Quantity
- 180 units (60 US; 120 OUS)
- Product code
- MUE
- FDA submissions
- K162268, K182951, K193334, K211215, K173576
- Distribution
- Us Nationwide-Worldwide Distribution
Product description
Senographe Pristina
Code information (models, lots, serial numbers)
GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879
Devices named in this recall
7 devices in the FDA device registry whose identifier appears in the recall's code information.
- Senographe Pristina EKB4Ge Medical Systems · Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina EKB6Ge Medical Systems · Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina NAY2Ge Medical Systems · Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina NAY3Ge Medical Systems · Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina EKB1Ge Medical Systems · Full field digital,system,x-ray,mammographic2 recalls0 reports
- Senographe Pristina EKB2Ge Medical Systems · Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina EKB3Ge Medical Systems · Full field digital, system, x-ray, mammographic2 recalls0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K162268, K182951, K193334, K211215, K173576 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Senographe Pristina MBE2Ge Medical Systems · Full Field Digital, System, X-Ray, Mammographic1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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