Shimadzu Medical Systems: MODEL: X-RAY R/F SYSTEM FLUOROspeed X1

Recall number

Z-0867-2022

Recalling firm

Shimadzu Medical Systems

Product

MODEL: X-RAY R/F SYSTEM FLUOROspeed X1

Status

Open, Classified

Initiated

2022-01-10

Posted

not on file

Terminated

not on file

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.

Root cause

Software design

Action

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

Quantity

25 systems

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

Lot, serial or model codes

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

510(k) numbers

["K191877"]

PMA numbers

not on file

Product code

JAA

Firm FEI

1000125362

Firm city

Torrance

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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