| Class 2 Device Recall SOMATOM Definition AS | |
Date Initiated by Firm | November 19, 2021 |
Create Date | January 10, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0473-2022 |
Recall Event ID |
89208 |
510(K)Number | K190578 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product | SOMATOM Definition AS-Computed tomography system
Model 8098027 |
Code Information |
Serial Numbers:
96278
96887
66027
64492
64541
64519
64427
67297
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96267
64864
96211
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95529
98418
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64785
95716
65998
66447
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66959
UDI: UDI 04056869003665 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
|
For Additional Information Contact | SAME 610-219-4834 |
Manufacturer Reason for Recall | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. |
FDA Determined Cause 2 | Software Design Change |
Action | Siemens issued Urgent Medical Device Correction letter CSAN CT067/21/S on November 19, 2021, to notify affected customers of the head image degradation issue and to provide them with a workaround solution. Letter states reason for recall, health risk and action to take:
To avoid potential misdiagnosis, it is mandatory to change to the new cupping correction setting CC = 4 immediately, restart the application, and (if applicable) reconstruct the raw data again.
Cupping correction setting CC = 4 is a further development of CC = 1: The Image impression is very similar to setting CC = 1 but an important improvement reduces possible artifacts. For customers who have routinely been using CC = 0 and CC = 2 instead of CC = 1, the image impression with CC = 4 will be different from what they are
used to.
Please note that the use of cupping correction CC = 4 may cause slightly altered CT numbers of non-water equivalent body materials or tissues in reconstructions with H-kernels and enabled iBHC (i.e., setting Bone or Iodine ) compared to results obtained with settings CC = 0, 1, or 2. For any quantitative interpretation of CT numbers, e.g., the mapping of HU to electron density, a recalibration is necessary Siemens is developing a technical solution, VB20_SP6 with high priority
.Siemens Healthineers is working with high priority on a solution for the described degradation. The solution will be provided with software version VB20_SP6. Your local service organization will contact you in due time and schedule an appropriate date for the installation of the solution. This solution will be provided to you free of charge. Please note that the Regional Unit Contact cannot schedule your appointment.
If you have any unresolved questions or require technical support, please contact your local applicable
specialist or our service organization at 1-800-888-7436.
Acknowledge Receipt of this Safety Advisory Notice
Please review, understand, and confirm acknowledgement of the informati |
Quantity in Commerce | 794 units |
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.
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510(K) Database | 510(K)s with Product Code = JAK
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