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Terminated

Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical Solutions, Malvern, PA 19355

FDA Recall Z-0732-2008 · Posted 2008-02-23

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2007-11-27
Date Terminated2008-09-17
Product Quantity10 units

Reason for Recall

Inconsistent data - A buffer overflow may occur between information system and picture system if the system experiences a high load. (e.g. RIS/PACS communication is unusally high)

Firm Action

The recalling firm issued a Customer Safety Advisory, via certified mail. to the affected customers on 11/27/07. The letter informs the customer of the issue and also provides instruction to detect and avoid its occurrence. In addition, the firm is developing a software update to correct the issue, which will be installed on the affected systems when it is released.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution, including states of AL, MO, NC, NY, OH, OR, TN, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071114SYNGO IMAGING (VERSION V30)Siemens AG Medical Solutions · 2007-05-22

Official Source

View FDA Recall →

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

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