Siemens Medical Solutions USA, Inc: SOMATOM Confidence -Computed tomography systems Model 10590100

Is my product affected?

SOMATOM Confidence -Computed tomography systems Model 10590100

• UPC 04056869011011

Check against the official notice below — it lists the full affected range.

What happened

Siemens Medical Solutions USA, Inc. is recalling 108 SOMATOM Confidence computed tomography (CT) systems nationwide that contain software version VB20_SP5. This software version may cause a significant reduction in the quality of head images produced by the affected devices, which could potentially lead to misdiagnosis of patients.

The recalled units are identified by specific serial numbers ranging from 100016 to 100486. The source document does not specify what remedy is available to consumers or what steps affected users should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

Details from the source

Reason for recall: Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. Distribution: US Nationwide distribution. Quantity: 108 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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