Shimadzu Medical Systems MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
Brand
Shimadzu Medical Systems
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Shimadzu Medical Systems is recalling MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On or about 1/7/2022, the firm sent an "Urgent: Voluntary Medical Device Recall Notice" to customers informing them that there is a potential issue with the adjustment procedure of the generator on the SonialVision (G$ and safire) Systems and FluoroSpeed X1 Systems. As a result of the Recalling Firm's investigation and testing it was proven that there is a problem with the adjustment procedure documented for the calibration of the system xray generator. This problem occurs during the calibration of the fluoroscopic mode which could cause x-ray radiation dose rate to exceed regulation and/or standards. As a result of the investigation, it was determined that the calibration procedure for the generator to instruct the installer requires updating. This problem if not corrected could cause improper calibration which would lead to dose levels above regulations. Therefore, the Recalling Firm will release notification to update calibration instructions and to conduct calibration of the system following revised calibration procedure. Customers are instructed to: -Check their systems for the affected generators/systems. -Contact their distributor to schedule a system update and calibration. -Pay attention to the following points until the calibration/update is completed: If the SID (distance between the X-ray focus and the FPD input surface) is 1200 mm or more, it has been confirmed that the dose rate does not exceed the specified value. If SID 1200 mm cannot be used and SID 1100 mm is used, the following points must be kept in mind until readjustment. When fluoroscopy is performed under the condition where the fluoroscopy tube voltage is maximum, the dose rate may increase by up to 8 percent from the adjustment value at the time of installation and exceed the dose regulation and/or standard value. Therefore, pay attention to the fluoroscopy cumulative time so as not to perform fluoroscopy for a long time under the condition where the fluoroscopy tube voltage is
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OR, PA, RI, SC, SD, TN, TX, WA, WV
Page updated: Jan 10, 2026