SOMATOM Edge Plus-Computed tomography system Model 1026700
Recall
- Recall Number
- Z-0474-2022
- Event Number
- 89208
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- JAK
- Status
- Open, Classified
- Root Cause
- Software Design Change
- Initiated
- November 19, 2021
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418
Description
SOMATOM Edge Plus-Computed tomography system Model 1026700
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
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
US Nationwide distribution.
80 units