Z-0862-2024Class II

Senographe Pristina

Name: Z-0862-2024 Senographe Pristina
Creator: GE Medical Systems, SCS
Published: 2023-12-26
License: https://open.fda.gov/license/

GE Medical Systems SCS / initiated 2023-12-26 / Open, Classified

FDA source

GE Medical Systems, SCS began a recall of Senographe Pristina on 2023-12-26. FDA classified it as Class II and gives the reason as "X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0862-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-26
Posted: 2024-02-08
Recalling firm: GE Medical Systems SCS
Product: Senographe Pristina
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: 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: Radiation Control for Health and Safety Act
Action: 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.
Quantity in commerce: 180 units (60 US; 120 OUS)
Distribution: Us Nationwide-Worldwide Distribution
Product codes and lots: GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0862-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0862-2024	Class II	Ongoing	FDA Mandated	2024-02-14	2024-02-08

Product code MUE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)