Siemens Medical Solutions USA, Inc SOMATOM Confidence -Computed tomography systems Model 10590100 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SOMATOM Confidence -Computed tomography systems Model 10590100
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Numbers: 100172 100091 100112 100362 100278 100158 100143 100129 100237 100238 100191 100356 100425 100216 100307 100325 100328 100329 100326 100239 100461 100213 100070 100062 100072 100022 100107 100241 100157 100055 100340 100347 100137 100267 100190 100252 100438 100046 100197 100092 100202 100313 100311 100043 100136 100189 100283 100156 100079 100049 100056 100147 100262 100018 100240 100117 100097 100274 100242 100099 100383 100059 100289 100312 100174 100073 100016 100182 100146 100058 100170 100175 100292 100090 100271 100463 100257 100273 100067 100160 100218 100367 100087 100309 100284 100207 100405 100261 100025 100338 100272 100053 100019 100421 100280 100357 100220 100214 100393 100394 100486 100140 100085 100279 100254 100353 100298 100379 UDI: UDI 04056869011011
Siemens Medical Solutions USA, Inc is recalling SOMATOM Confidence -Computed tomography systems Model 10590100 due to Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026