syngo.plaza, Model number 10592457. Intended use: radiological image processing system.

FDA device recall Z-2275-2012 · posted 2012-08-27 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.

Action taken

The firm initiated their recall/correction of this device on July 18, 2012 by sending a "Customer Safety Advisory Notice" letter, dated July 12, 2012, to their consignees. The letter identified the affected product along with the malfunction. It also discussed the steps the user can take to avoid the issue. Users were asked to not use the mentioned functions for images from those modalities until the issue was resolved and the system was updated with the software version containing the solution. Users were to contact their local Siemens Service in order to plan for the updated software version that will resolve the issue. Additionally, users should place the safety advisory notice in the system's instructions for use, and personnel should be instructed accordingly and maintain awareness. If the device was sold and is no longer in the users' possession, the notice should be forwarded to the new owner and the firm should be notified of the new owner.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

14

Distribution

Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.

Date initiated

2012-07-18

Date posted

2012-08-27

Date terminated

2014-01-24

Location

Malvern, PA

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