Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system

FDA device recall Z-1975-2013 · posted 2013-08-15 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.

Action taken

The firm, Siemens, notified their customers on March 4, 2013 and sent a "Customer Safety Advisory Notice" letter dated April 03, 2013. The letter described the product, problem and actions to be taken. The customers were instructed to always check whether the laterality information is displayed in the image text of mammography images; if not, the DICOM header is accessible and can be checked for the tag "Laterality" (0020, 0060). If a system is not able to provide the DICOM tag "Image Laterality" (0020, 0062), configuring the image text by adding the tag was proposed. If you have sold the device/equipment and it is no longer in your possession, forward this safety notice to the new owner of the device/equipment and inform us about the new owner of the device/equipment. This issue will be resolved in the syngo.plaza software version VA20D_HF04 which is planned to be released in 02/2013. Customers were also instructed to contact the local Siemens service office to plan the update. If you have any questions, contact the SYNGO CEO or Vice President Quality at +49 (9131) 84-4874 or email to: michael.mlb.braun@siemens.com.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

6

Distribution

Nationwide distribution: FL, MA, KS, NY, OH, PA, TX and WI.

Date initiated

2013-03-04

Date posted

2013-08-15

Date terminated

2015-03-09

Location

Malvern, PA

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