Recall archive / FDA device enforcement
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Numbe... — FDA record Z-1164-2023
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 Dec 21, 2022. 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
- Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
- Reason
- Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 4 units. Expanded Recall: 93 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1164-2023
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 | UDI: N/A S/N: 60040 60018 60223 60015 Expanded Recall 2/24/23: S/N: 60011 60037 60041 60043 60051 60055 60056 60062 60067 60071 60072 60075 60076 60081 60087 60089 60092 60093 60095 60103 60111 60114 60118 60133 60138 60140 60141 60143 60146 60155 60162 60171 60172 60173 60178 60183 60184 60186 60187 60188 60192 60194 60196 60204 60208 60214 60219 60220 60221 60225 60227 60228 60230 60231 60234 60238 60239 60255 60259 60262 60264 60267 60273 60274 60277 60279 60286 60404 60408 60409 60412 60413 60414 60416 60417 60423 60424 60425 60429 60433 60436 60440 60441 60445 60446 60450 60452 60459 60464 60465 60466 60469 60473 |
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
- Mar 1, 2023
- Recall initiation date
- Dec 21, 2022
- Center classification date
- Feb 23, 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.