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Terminated

Seneographe 600 Mammography X-Ray Systems (all versions)

FDA Recall Z-0287-04 · Posted 2004-07-20

Recalling FirmGeneral Electric Med Systems
Recall StatusTerminated
Product CodeIZH
Date Initiated2004-02-06
Date Terminated2005-11-23

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide in the United States

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K881882SENOGRAPHE 600T AND 600TS SENIX HFGeneral Electric Co. · 1988-05-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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