Recall Z-0283-04 ยท IZH System, X-Ray, Mammographic
General Electric Med Systems
Seneographe DMR Mammography X-Ray System (all versions)
| Date | Jul 20, 2004 (initiated Feb 6, 2004) |
| Status | Terminated |
| Reason | 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913418 | SENOGRAPHE DMR/SMR/DM General Electric Co., Jan 6, 1992 |