Recall Z-3005-2020— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-3005-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-19

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2020-08-19, terminated 2023-04-19. It names one FDA 510(k) clearance: K192065. Product: Software: 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. Reason: 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.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2020-08-19
Terminated: 2023-04-19
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K192065 — Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.·cleared 2019-09-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Software: 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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.