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Terminated

Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163

FDA Recall Z-1095-04 · Posted 2004-07-20

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2004-04-01
Date Terminated2004-09-21

Reason for Recall

Recalling firm became aware of a potential problem through the submission of a product complaint to the firm reporting the Image Navigator feature in the MagicView 300 VA42A or VA42B software are not being imported accurately to certain CT or MR images.

Firm Action

The recalling firm has issued a letter to their Siemens Service Engineers to visit each affected sites, in order to correct the software problems. Additionally, a letter advising of the software problems was also sent to the Radiology Director at the affected sites, informing them of the 'Customer Safety Advisory' and the pending visit of the Seimens Service Engineers to perform a software update. Along with these letters, is a set of instructions detailing the potential risks and that a representative from the recalling firm will be contacting the medical facilities.

Root Cause

Other

Distribution Pattern

Nationwide. The product was shipped to various medical facilities, in the following states, AK, GA, FL, IA, MA, MI, MO, NH, NJ, NY, NV, OK, PA, TX, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935694SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADESiemens Medical Solutions USA, Inc. · 1994-03-07

Official Source

View FDA Recall →

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

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