| Class 2 Device Recall SOMATOM go.Now | |
Date Initiated by Firm | May 28, 2019 |
Create Date | July 02, 2019 |
Recall Status1 |
Terminated 3 on March 31, 2023 |
Recall Number | Z-1916-2019 |
Recall Event ID |
83081 |
510(K)Number | K173632 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is 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. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. |
Code Information |
Serial Number: 111379 111374 111307 111225 111313 111350 111306 111281 111323 111219 111232 111271 111351 111369 111332 111370 111266 111371 111355 111310 111308 111328 111345 111310 111319 111286 111378 111338 111236 111352 111324 111344 111233 111368 111366 111230 111299 111315 111273 111249 111373 111289 111250 111317 111333 111297 111237 111341 111367 111303 111293 111302 111277 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact | Rebecca Tudor 610-219-4834 |
Manufacturer Reason for Recall | The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user
notifications. This may cause a delay in diagnosis or patient scans. |
FDA Determined Cause 2 | Software design |
Action | Urgent Medical Device Correction letters dated 5/24/19 were sent to customers. |
Quantity in Commerce | 53 |
Distribution | US Nationwide distributed in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and Puerto Rico. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JAK
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