Lower risk Medical device recall · FDA · Published January 10, 2022

Shimadzu X-Ray TV System SonialVision Safire17: Radiation Dose Risk

Shimadzu Medical Systems recalls X-Ray TV System SonialVision Safire17 models due to potential radiation dose exceeding safety limits in fluoroscopic mode. Affected units have specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0869-2022Medical device Shimadzu Medical Systems ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmShimadzu Medical Systems20101 S Vermont Ave · Torrance, CA 90502-1328

✎ GovInfoNow plain-language explainer

Shimadzu Medical Systems is recalling X-Ray TV System SonialVision Safire17 models because radiation levels may exceed safe limits during fluoroscopy. This could lead to unnecessary radiation exposure for patients or staff if the device is used without proper adjustments. Read more at govinfonow.com/recall/61283-shimadzu-x-ray-tv-system-sonialvision-safire17-radiation-dose-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61283-shimadzu-x-ray-tv-system-sonialvision-safire17-radiation-dose-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0869-2022

Cite this page

“Shimadzu X-Ray TV System SonialVision Safire17: Radiation Dose Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61283-shimadzu-x-ray-tv-system-sonialvision-safire17-radiation-dose-risk. Based on FDA recall #Z-0869-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0869-2022%22&limit=1).

The FDA announced on Jan. 10, 2022, that Shimadzu Medical Systems is recalling its SonialVision safire x-ray systems due to a hazard where irradiated x-rays may exceed specified radiation dose rates in fluoroscopic mode.

How to tell if you have it

Brand: Shimadzu Medical Systems
Product: X-RAY TV SYSSTEM SONIALVISION safire17
Model: SonialVision safire
Generator Number: D150-40
Serial Numbers: 3M5249D41006, 3M5249D2A004, 3M5249D34001, 3M5249D37006, 3M5249D32012, 3M5249D35002, 3M5249D1C013, 3M5249D31009, 3M5249D29002, 3M5249D33003, 3M5249D2C004, 3M5249D22013
Quantity: 12 systems

The hazard

According to the FDA, the hazard stems from inadequate adjusting criteria during installation, which may cause the irradiated x-ray to exceed the radiation dose rate specified in CFR 1020.32 in specific cases of fluoroscopic mode.

Context

GovInfoNow's records show Shimadzu Medical Systems has 6 other recalls on record since Jan. 12, 2018. Other recent recalls of similar products include AGFA DR 800 X-Ray System Recall (Nov. 18, 2025), Siemens ARTIS pheno X-ray System Recalled (March 9, 2026), and FUJIFILM FDR Visionary Suite CH-200 X-ray Device Recall (Jan. 9, 2026).

How to tell if you have this one

Check for the model name 'SonialVision safire17' and serial numbers starting with 3M5249D followed by specific digits listed in the recall notice.

Brand
Shimadzu Medical Systems
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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

Recall number	Product, codes & lots	Quantity
Z-0867-2022	MODEL: X-RAY R/F SYSTEM FLUOROspeed X1; 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	25 systems
Z-0868-2022	MODEL: X-RAY TV SYSTEM SONIALVISION G4; Model: SonialVision G4 Generator Number: D150-40 Serial Numbers: 41C35166C003 41C3536B4001 41C351683006 41C3516B3001 41C35169C002 41C351699002 41C351699001 41C3517AA001 41C35169B002 41C351671001 41C3516A3001 41C351661002 41C351671007 41C351683003 41C351671005 41C35179B004 41C351674001 41C35168B002 41C3517AA002 41C351685004 41C35165B002 41C3535A5001 41C353597001 41C35359C001 41C351674004 41C351685003 41C35164C001 41C351641001 41C351671004 41C351679001 41C3535A1001 41C3535A3001 41C351664004 41C351679006 41C351684004 41C351674002 41C3535A2002 41C351669002 41C351646002 41C35164A001 41C35359C002 41C351692001 41C35168B001 41C351653004 41C351664002 41C351673004 41C351663002 41C35164B001 41C351683001 41C351683002 41C351799001 41C351686002 41C351646001 41C351679005 41C351693003 41C351665002 41C35179A001 41C35165A003 41C35168A003 41C35179B005 41C35179B003 41C351671006 41C351689001 41C351799002 41C351641002 41C351671002 41C351676002 41C35165A001 41C351643001 41C35165A002 41C351655001 41C351695003 41C351647001 41C35166A002 41C351693002 41C351695001 41C351664005 41C351673003 41C35166C001 41C3535AC001 41C35166A001 41C35168B003 41C35169C001 41C3517B1001 41C3518B4002 41C351653002 41C3518B4001 41C35168A004 41C351665003 41C351678002 41C351684001 41C351683005 41C351693001 41C351671003 41C35179C001 41C351677001 41C35167A001 41C35165B001 41C351676001 41C351662001 41C35168C002 41C351668002 41C351679004 41C351677002 41C35179B001 41C351684005 41C351692003 41C351653003 41C351666002 41C351682002 41C351685001 41C351677003 41C353597002 41C3517A2002 41C351661001 41C35168C005 41C35168A002 41C35169A001 41C351663001 41C351692004 41C35168C004 41C351664001 41C351681001 41C351651002 41C351684006 41C3535A2001 41C351679007 41C351799003 41C351667001 41C351678001 41C351683004 41C351681002 41C351656001 41C351655003 41C3516B3002 41C3517B3002 41C3518B5001 41C3518B5002 41C3518B7001 41C3536B7001 41C351656002 41C35166C002 41C35168C001 41C351679002 41C351651001 41C351686001 41C351692002 41C3517A2001 41C35168A001 41C35166A003 41C351665001 41C351659001 41C3535A3002 41C351653005 41C351684003 41C3517A3001 41C351685002 41C3517A3002 41C351688001 41C351666001 41C351673002 41C351793001 41C351641003 41C351682001 41C351673001 41C35169B001 41C351695002 41C351655002 41C351679003 41C35168C003 41C35179B002 41C3517B1002 41C3517B3001 41C351668001 41C351669001 41C351654002	176 systems
Z-0869-2022	MODEL: X-RAY TV SYSSTEM SONIALVISION safire17; Model: SonialVision safire: Generator Number: D150-40 Serial Numbers: 3M5249D41006 3M5249D2A004 3M5249D34001 3M5249D37006 3M5249D32012 3M5249D35002 3M5249D1C013 3M5249D31009 3M5249D29002 3M5249D33003 3M5249D2C004 3M5249D22013	12 systems

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Look for serial numbers starting with 3M5249D followed by specific digits listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in 37 states.

FDA 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 read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Washington, West Virginia.

Recall timeline

FDA published this recall 3 months after the firm started it.

Jan 10, 2022Firm started the recall
Apr 6, 2022FDA classified it Class II
Apr 13, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/61283-shimadzu-x-ray-tv-system-sonialvision-safire17-radiation-dose-risk">Shimadzu X-Ray TV System SonialVision Safire17: Radiation Dose Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0869-2022 (January 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0869-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.