Recall archive / FDA device enforcement
Surpria 64: Software Version V3.11, V3.22 — FDA record Z-1750-2022
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 Jul 12, 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
- Surpria 64: Software Version V3.11, V3.22
- Reason
- Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
- Classification
- Class II
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Quantity
- 16 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1750-2022
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: (01)04573596200520(11)220215(21)W5086(250)G1Z0211021 (01)04580292766601(11)200130(21)W8013(250)G1Z0098019 (01)04580292766601(11)200226(21)W8014(250)G1Z0130719 (01)04580292766601(11)201217(21)W8015(250)G1Z0024020 (01)04580292766601(11)210217(21)W8016(250)G1Z0216720 (01)04580292766601(11)210528(21)W8017(250)G1Z0239620 (01)04580292766601(11)210610(21)W8018(250)G1Z0039321 (01)04580292766601(11)210628(21)W8019(250)G1Z0223420 (01)04573596200520(11)210727(21)W8020(250)G1Z0087821 (01)04573596200520(11)210825(21)W8021(250)G1Z0139021 (01)04573596200520(11)211012(21)W8022(250)G1Z0112721 (01)04573596200520(11)211026(21)W8023(250)G1Z0156921 (01)04573596200520(11)220113(21)W8024(250)G1Z0043121 (01)04573596200520(11)220113(21)W8025(250)G1Z0240221 (01)04573596200520(11)220204(21)W8026(250)G1Z0244021 (01)04573596200520(11)220204(21)W8027(250)G1Z0249821 (01)04573596200520(11)220214(21)W8028(250)G1Z0249921 Serial Numbers: G1Z0098019 G1Z0130719 G1Z0024020 G1Z0216720 G1Z0239620 G1Z0039321 G1Z0223420 G1Z0087821 G1Z0139021 G1Z0112721 G1Z0156921 G1Z0043121 G1Z0240221 G1Z0244021 G1Z0249821 G1Z0249921 |
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
- Sep 21, 2022
- Recall initiation date
- Jul 12, 2022
- Center classification date
- Sep 15, 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.