Class 2 Device Recall Syngo Imaging XS

• Date Initiated by Firm: September 29, 2009
• Date Posted: November 16, 2009
• Recall Status: Terminated on July 05, 2012
• Recall Number: Z-0270-2010
• Recall Event ID: 53563
• 510(K)Number: K082430
• Product Classification: Picture archiving and communications system - Product Code LLZ
• Product: Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression.
• Code Information: Model number 7502029 - Serial numbers: 9620, 9621, 9622, 9623, 9624, 9625, 9630, 9631, 9632, 9633, 9634, 9639, 9640, 12068, 12271, 13090, 13358, 13428, 13480, 13637, 13727, 13742, 13945, 13971, 13979, 14059, 14086, and 14960.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355
• For Additional Information Contact: Customer Service; 610-219-6300
• Manufacturer Reason for Recall: Distorted image. The "Distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another source.
• FDA Determined Cause: Software design
• Action: The recalling firm issued a Customer Safety Advisory notice dated 9/14/09 to all affected customers via Update Instructions IM100/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. To avoid the potential risk of the issue, the local compression function can be disabled as described in the letter. Depending on the image data, the disabling of compression will result in increased storage usage. The issue will be resolved in the release of version VA70B. For all potentially affected customers with "JPEG Compression" license an update instruction will be released which defines the necessary corrective actions in case of "Distorted" images. The update instruction will be performed on request by the customer service group. Further questions regarding this issue are directed to the local SIEMENS Uptime Service Center or +49 (9131) 84-2056.
• Quantity in Commerce: 28 units
• Distribution: The product was shipped to medical facilities in CA, FL, GA, IL, MD, MI, MO, NE, NC, NY, OH, PA, TN, TX, and WV.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LLZ