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Terminated

Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system

FDA Recall Z-1318-2009 · Posted 2009-06-01

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAQ
Date Initiated2009-01-21
Date Terminated2009-06-01
Product Quantity4 units

Reason for Recall

Table may unintentionally lift during procedure

Firm Action

Siemens Medical Solutions issued a Safety Advisory Notice dated 1/22/09 which informs the customers of the potential issues and recommends that they stop using their MammoTest System until the prone table has been repaired. Linear Medical visited the customers to repair the weld joint on the prone table by January 23, 2009.

Root Cause

Nonconforming Material/Component

Distribution Pattern

USA distribution to IL, NY, SC, and WA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042095MAMMOTESTFischer Imaging Corp. · 2004-10-29

Official Source

View FDA Recall →

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

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