Recall archive / FDA device enforcement
Artis Q.zen biplane, Model Number 10848355 — FDA record Z-0980-2022
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 Feb 23, 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
- Artis Q.zen biplane, Model Number 10848355
- Reason
- If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 69 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0980-2022
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 | UDI: 4056869010038; Serial Numbers: 123225 123245 123026 123043 123031 123053 123202 123050 123248 123008 123255 123252 123259 123035 123211 123247 123011 123003 123032 123208 123209 123231 123246 123254 123025 123036 123220 123221 123222 123206 123207 123268 123240 123262 123265 123219 123505 123213 123250 123251 123022 123229 123205 123502 123201 123023 123024 123224 123232 123233 123234 123501 123027 123049 123249 123055 123056 123037 123264 123010 123046 123052 123200 123015 123016 123244 123212 Additional Serial Numbers as of 10/4/23: 123216 123239 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US 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
- Apr 27, 2022
- Recall initiation date
- Feb 23, 2022
- Center classification date
- Apr 21, 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.