Z-2131-2019Class II

GE Senographe Pristina -

Name: Z-2131-2019 GE Senographe Pristina -
Creator: GE Healthcare, LLC
Published: 2019-05-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-05-16 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast... on 2019-05-16. FDA classified it as Class II and gives the reason as "Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2131-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-16
Posted: 2019-07-30
Terminated: 2020-12-16
Recalling firm: GE Healthcare
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 mammographic systems.
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: On May 17, 2019, GE Healthcare sent letters to all of their consignees advising them of the recall, providing them with new instructions for use, and requesting that they complete the enclosed MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED forms. GE will follow-up and correct these systems,
Quantity in commerce: 82
Distribution: Worldwide distribution - US nationwide distribution in the states of AZ, CA, FL, GA, IL, MI, MN, NC, NJ, NY, PA, TX, and VT, and countries of Algeria, Australia, Belgium, Canada, Chile, Columbia, Czech Republic, Finland, France, Germany, Hungary, Iceland, Japan, Korea (Republic of), Kuwait, Lebanon, New Zealand, Norway, Poland, Saudi Arabia, Senegal, South Africa, Sri Lanka, Sweden, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.
Product codes and lots: Serial# 716784BU4, 716785BU1, 716786BU9, 716787BU7, 716788BU5, 718583BU8, 718584BU6, 718585BU3, 718586BU1, 718587BU9, 718588BU7, 718589BU5, 718591BU1, 718592BU9, 718593BU7, 718594BU5, 718595BU2, 718596BU0, 718597BU8, 718598BU6, 718599BU4 , 718600BU0, 718601BU8, 718602BU6, 722648BU3, 722649BU1, 722653BU3, 722654BU1, 722655BU8, 722656BU6, 722657BU4, 730124BU5, 730125BU2, 730126BU0, 730292BU0, 730293BU8, 730663BU2, 730664BU0, 730665BU7, 732049BU2, 732050BU0, 732303BU3, 732304BU1, 732305BU8, 732362BU9, 732363BU7, 732448BU6, 732449BU4, 732450BU2, 732727BU3, 732728BU1, 733031BU9, 733903BU9, 733904BU7, 734170BU4, 734206BU6, 734840BU2, 735432BU7, 735779BU1, 736006BU8, 736007BU6, 736008BU4, 736366BU6, 736588BU5, 738021BU5, 738356BU5, 738357BU3 , 738358BU1, 738557BU8, 738573BU5, 738586BU7, 738587BU5, 738712BU9, 738792BU1, 738794BU7, 738795BU4, 738864BU8, 739150BU1 and 739721BU9.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2131-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2131-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2132-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30

Product code MUE

K162268Class IISenographe PristinaGE Healthcare / cleared 2016-11-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)