Date Initiated by Firm |
July 03, 2019 |
Create Date |
August 14, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2268-2019 |
Recall Event ID |
83377 |
510(K)Number |
K103127
|
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product |
SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies). |
Code Information |
Serial Numbers: 98474 92280 92261 65370 66032 66649 65299 92298 64516 92335 92300 66062 64218 92313 92296 92254 64051 92342 92277 92307 92336 92315 92288 98473 65145 65493 92323 92321 92243 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
|
For Additional Information Contact |
610-219-4834
|
Manufacturer Reason for Recall |
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
|
FDA Determined Cause 2 |
Software design |
Action |
Siemens has initiated a Customer Safety Advisory Notice (CSAN) to all affected customers via CT035/19/S. Customers with valid email addresses were emailed a copy of the CSAN on 07/03/2019 via Adobe Mega Sign. The CSAN were distributed to the remaining customers without a valid email address via certified mail on 07/12/2019. Additionally, a solution to eliminate the root cause of this problem (application of software update VB20) will be distributed to all affected customers free of charge. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. |
Distribution |
US Nationwide distribution. |
Total Product Life Cycle |
TPLC Device Report
|
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA INC.
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