Recall archive / FDA device enforcement
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200 — FDA record Z-0195-2024
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 Sep 12, 2023. 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
- Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
- Reason
- Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 237 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0195-2024
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 | ***Updated 12/4/23*** UDI-DI: 04056869153490 S/N: 40013 40014 40015 40018 40020 40023 40030 40032 40033 40034 40035 40036 40039 40040 40046 40047 40048 40049 40050 40051 40052 40054 40055 40057 40058 40062 40070 40073 40075 40076 40077 40078 40080 40083 40084 40093 40094 40095 40102 40103 40104 40107 40108 40109 40110 40111 40116 40117 40119 40121 40122 40123 40124 40125 40126 40130 40134 40135 40137 40139 40157 40158 40160 40161 40162 40163 40164 40167 40168 40169 40170 40171 40174 40175 40176 40188 40189 40190 40191 40192 40193 40194 40196 40206 40208 40215 40220 40226 40228 40230 40231 40234 40236 40238 40239 40240 40242 40244 40245 40246 40248 40250 40251 40252 40255 40256 40257 40259 40261 40263 40264 40265 40266 40267 40268 40270 40271 40273 40276 40314 40315 40317 40318 40322 40323 40324 40336 40339 42001 42002 42003 42004 42005 42006 42010 42018 42024 42025 42028 42032 42033 42037 42040 42041 42042 42045 42046 42052 42057 42061 42068 42069 42082 42087 42094 42101 42111 42140 42141 42146 42147 42148 42156 42160 42161 42185 42186 42187 42188 42189 42190 42191 42196 42199 42202 43000 43002 43003 43006 43007 43013 43022 43023 43025 43026 43027 43028 43029 43031 43033 43034 43037 43042 43044 43045 43046 43048 43049 43055 43058 43060 43061 43062 43063 43072 43073 43076 43079 43086 43095 43105 43106 43108 43112 43142 43143 43150 43161 43163 43177 43193 43208 43222 43226 43231 43257 43261 43279 43283 43286 43289 43291 43296 43297 43298 43319 43339 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide
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
- Nov 8, 2023
- Recall initiation date
- Sep 12, 2023
- Center classification date
- Oct 27, 2023
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.