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Siemens Medical Solutions USA, Inc Recall 89208

Description: SOMATOM Confidence -Computed tomography systems Model 10590100

Siemens Medical Solutions USA, Inc Recall 89208 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0472-2022
Event ID89208
Event DescriptionSOMATOM Confidence -Computed tomography systems Model 10590100
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity108 units
Recall ReasonSoftware version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Device Classification20220119
Device Code InfoSerial 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
Center Classification Date20220110
Recall Initiation Date20211119
Recalling FirmSiemens Medical Solutions USA, Inc
Initial Notification Letter
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