Recall archive / FDA device enforcement
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 — FDA record Z-0867-2022
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 Jan 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
- MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
- Reason
- It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
- Classification
- Class II
- Recalling firm
- Shimadzu Medical Systems
- Quantity
- 25 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0867-2022
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 | Model: FLUOROspeed X1 Generator Number: D150-40 Serial Numbers: MQ493E19C001 MQ493E3B8002 MQ493E3B9001 MQ493E1B4001 MQ493E1A1003 MQ493E1A3001 MQ493E1B5001 MQ493E3B8001 MQ493E1A5001 MQ493E1A1005 MQ493E1A2001 MQ493E1A4001 MQ493E1B6002 MQ493E1A8001 MQ493E1B4002 MQ493E1A4003 MQ493E1A4002 MQ493E1B6001 MQ493E1A2002 MQ493E1AC001 MQ493E1A1002 MQ493E19C002 MQ493E1A3003 MQ493E1A1004 MQ493E1A3002 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV. O.U.S.: N/A
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Washington
- West Virginia
Dates in the source
- Report date
- Apr 13, 2022
- Recall initiation date
- Jan 10, 2022
- Center classification date
- Apr 6, 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.