Z-0287-04

Seneographe 600 Mammography X-Ray Systems (all versions)

Name: Z-0287-04 Seneographe 600 Mammography X-Ray Systems (all versions)
Creator: General Electric Med Systems
Published: 2004-02-06
License: https://open.fda.gov/license/

GE Healthcare / initiated 2004-02-06 / Terminated

FDA source

General Electric Med Systems began a recall of Seneographe 600 Mammography X-Ray Systems (all versions) on 2004-02-06. The reason FDA records is "The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0287-04
Status: Terminated
Initiated: 2004-02-06
Posted: 2004-07-20
Terminated: 2005-11-23
Recalling firm: GE Healthcare
Product: Seneographe 600 Mammography X-Ray Systems (all versions)
Product code: IZH System, X-Ray, Mammographic
Reason for recall: The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.
FDA root cause: Other
Action: The consignees were sent 'Regulatory Notice' letters dated February 6, 2004. The letters informed the consignees of the violations and provided them with the technical specifications which needed to be provided.
Distribution: Nationwide in the United States
Product codes and lots: All serial numbers

Product code IZH

K881882Class IISenographe 600T and 600Ts Senix HFGeneral Electric Co. / cleared 1988-05-25

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)