Recall archive / FDA device enforcement
SOMATOM Confidence -Computed tomography systems Model 10590100 — FDA record Z-0472-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 19, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- SOMATOM Confidence -Computed tomography systems Model 10590100
- Reason
- Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 108 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0472-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 19, 2022
- Recall initiation date
- Nov 19, 2021
- Center classification date
- Jan 10, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.