Recall archive / FDA device enforcement
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000 — FDA record Z-1294-2022
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 Jun 10, 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 Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
- Reason
- A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 136 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1294-2022
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-DI: 04056869046877 Serial numbers: 164140 164138 164159 164331 164332 164033 164287 164282 164210 164183 164184 164311 164142 164312 164071 164328 164034 164318 164244 164306 164155 164340 164189 164271 164277 164173 164292 164231 164095 164057 164054 164055 164132 164329 164072 164190 164048 164333 164025 164026 164027 164338 164094 164241 164326 164267 164186 164068 164121 164157 164019 164152 164161 164013 164069 164213 164073 164257 164293 164263 164298 164060 164083 164113 164021 164066 164362 164124 164125 164366 164279 164075 164074 164084 164086 164098 164028 164153 164330 164172 164295 164353 164234 164321 164242 164270 164275 164315 164344 164163 164158 164053 164171 164297 164134 164253 164188 164063 164064 164299 164300 164105 164160 164024 164080 164049 164240 164359 164227 164228 164018 164022 164250 164061 164187 164115 164011 164204 164205 164211 164212 164216 164100 164097 164269 164303 164322 164196 164355 164352 164168 164319 164201 164202 ***Updated 9/13/23*** 164088 164193 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Brazil Canada China Colombia Denmark Finland France Germany Hungary Indonesia Iran Italy Japan Kuwait Mexico Monaco Netherlands Norway Poland Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom United States Vietnam
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
- Jul 6, 2022
- Recall initiation date
- Jun 10, 2022
- Center classification date
- Jun 27, 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.