Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Device Recalls
  • Print
  • Share
  • E-mail
-
 Medical Device Recallssee related information
Date Initiated by FirmAugust 19, 2020
Create DateSeptember 23, 2020
Recall Status1 Terminated 3
Recall NumberZ-3005-2020
Recall Event ID 86185
ProductSoftware: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information ContactSAME
610-219-4834
Manufacturer Reason
for Recall		Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location
ActionSiemens Medical Solutions USA, Inc. issued Customer Safety Advisory Letter (CSAN) SY051/20/S on August 19, 2020 via email/hand delivery by Siemens Customer Service Engineer,. The letter states reason for recall, health risk and action to take: we highly recommend performing the laser calibration and the quality assurance procedure for the laser offset after every RT Image Suite software update.Please update the calibration offset in the MM RT Image Suite Configuration dialog accordingly . Details of this procedure are documented in Chapter 13.2 (Laser configuration) of your user manual. If you have any questions or require technical support, please contact our service organization at 1-800-888-7436. The technical solution distributed via SY040/20/S. Distribution of SY040/20/S (VB40B_HF01) will be distributed to all affected customers, free of charge. Distribution of SY040/20/S began on August 26, 2020. SY040/20/S will be installed with support from your local service organization
Quantity in Commerce64 systems US
DistributionUS Nationwide distribution.
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-