Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and F...

FDA Device Recall #Z-0499-2026 — Class II — October 16, 2025

Recall Summary

Recall Number Z-0499-2026
Classification Class II — Moderate risk
Date Initiated October 16, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Location Kyoto
Product Type Devices
Quantity 1,766 devices

Product Description

Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.

Reason for Recall

Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.

Distribution Pattern

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SM, SC, SD, TN, TX, VA, WA, and WI. The countries of Dominica, Grand Bahama, Haiti, and Saint Maarten.

Lot / Code Information

Model Numbers: CH-200. UDI code: 04540217014484. Serial Numbers: 3ZC5C2A84014, 3ZC5C2A85003, 3ZC5C2A77013, 3ZC5C2A86013, 3ZC5C2A75012, 3ZC5C2A76002, 3ZC5C2A76016, 3ZC5C2A76026, 3ZC5C2A79003, 3ZC5C2A84008, 3ZC5C2A73001, 3ZC5C2A87008, 3ZC5C2A7A001, 3ZC5C2A76018, 3ZC5C2A79001, 3ZC5C2A7A002, 3ZC5C2A7B001, 3ZC5C2A85015, 3ZC5C2A81001, 3ZC5C2A86003, 3ZC5C2A7C007, 3ZC5C2A84002, 3ZC5C2A7B019, 3ZC5C2A77010, 3ZC5C2A73006, 3ZC5C2A74004, 3ZC5C2A75002, 3ZC5C2A75005, 3ZC5C2A75006, 3ZC5C2A75007, 3ZC5C2A76010, 3ZC5C2A76013, 3ZC5C2A76022, 3ZC5C2A77011, 3ZC5C2A77012, 3ZC5C2A77014, 3ZC5C2A77023, 3ZC5C2A78002, 3ZC5C2A78003, 3ZC5C2A79002, 3ZC5C2A7C006, 3ZC5C2A7C016, 3ZC5C2A82004, 3ZC5C2A83002, 3ZC5C2A85010, 3ZC5C2A85016, 3ZC5C2A85018, 3ZC5C2A86002, 3ZC5C2A86009, 3ZC5C2A86011, 3ZC5C2A87010, 3ZC5C2A88003, 3ZC5C2A88005, 3ZC5C2A81002, 3ZC5C2A85017, 3ZC5C2A7B002, 3ZC5C2A86004, 3ZC5C2A85005, 3ZC5C2A71003, 3ZC5C2A86010, 3ZC5C2A81004, 3ZC5C2A73012, 3ZC5C2A73013, 3ZC5C2A73014, 3ZC5C2A76006, 3ZC5C2A76019, 3ZC5C2A76027, 3ZC5C2A77003, 3ZC5C2A7B015, 3ZC5C2A85019, 3ZC5C2A88008, 3ZC5C2A77002, 3ZC5C2A85002, 3ZC5C2A85001, 3ZC5C2A74005, 3ZC5C2A72005, 3ZC5C2A73002, 3ZC5C2A73009, 3ZC5C2A73010, 3ZC5C2A74007, 3ZC5C2A76008, 3ZC5C2A76009, 3ZC5C2A76017, 3ZC5C2A77001, 3ZC5C2A77009, 3ZC5C2A77017, 3ZC5C2A78005, 3ZC5C2A78006, 3ZC5C2A79007, 3ZC5C2A7B008, 3ZC5C2A7B011, 3ZC5C2A7B016, 3ZC5C2A7C014, 3ZC5C2A7C017, 3ZC5C2A81005, 3ZC5C2A81006, 3ZC5C2A81014, 3ZC5C2A84009, 3ZC5C2A85011, 3ZC5C2A85013, 3ZC5C2A75008, 3ZC5C2A85009, 3ZC5C2A7B009, 3ZC5C2A76001, 3ZC5C2A7C009, 3ZC5C2A7C010, 3ZC5C2A87009, 3ZC5C2A7C005, 3ZC5C2A7B013, 3ZC5C2A7B014, 3ZC5C2A73003, 3ZC5C2A77005, 3ZC5C2A74006, 3ZC5C2A81007, 3ZC5C2A75003, 3ZC5C2A72002, 3ZC5C2A72003, 3ZC5C2A72004, 3ZC5C2A72006, 3ZC5C2A73011, 3ZC5C2A74002, 3ZC5C2A75004, 3ZC5C2A76007, 3ZC5C2A76014, 3ZC5C2A76015, 3ZC5C2A77007, 3ZC5C2A77008, 3ZC5C2A77015, 3ZC5C2A77016, 3ZC5C2A77019, 3ZC5C2A77022, 3ZC5C2A79004, 3ZC5C2A7B006, 3ZC5C2A7B012, 3ZC5C2A7B018, 3ZC5C2A7C008, 3ZC5C2A81008, 3ZC5C2A82001, 3ZC5C2A84010, 3ZC5C2A84011, 3ZC5C2A85006, 3ZC5C2A85007, 3ZC5C2A86007, 3ZC5C2A87007, 3ZC5C2A88002, 3ZC5C2A88006, 3ZC5C2A87011, 3ZC5C2A87012, 3ZC5C2A86012, 3ZC5C2A77004, 3ZC5C2A7B003, 3ZC5C2A74008, 3ZC5C2A75001, 3ZC5C2A76011, 3ZC5C2A77021, 3ZC5C2A7B004, 3ZC5C2A7B007, 3ZC5C2A7B010, 3ZC5C2A7C015, 3ZC5C2A85012, 3ZC5C2A86005, 3ZC5C2A87002, 3ZC5C2A87003, 3ZC5C2A76024, 3ZC5C2A77018, 3ZC5C2A79006, 3ZC5C2A81003, 3ZC5C2A82002, 3ZC5C2A86008, 3ZC5C2A87013, 3ZC5C2A88001, 3ZC5C2A77020, 3ZC5C2A83001, 3ZC5C2A85004, 3ZC5C2A85008, 3ZC5C2A73005, 3ZC5C2A78004, 3ZC5C2A79005, 3ZC5C2A7B017, 3ZC5C2A7C001, 3ZC5C2A82003, 3ZC5C2A83004, 3ZC5C2A84001, 3ZC5C2A74010, 3ZC5C2A72001, 3ZC5C2A73004, 3ZC5C2A73008, 3ZC5C2A87005, 3ZC5C2A76004, 3ZC5C2A76025, 3ZC5C2A7A003, 3ZC5C2A7C004, 3ZC5C2A7C011, 3ZC5C2A81011, 3ZC5C2A81013, 3ZC5C2A84003, 3ZC5C2A74001, 3ZC5C2A87004, 3ZC5C2A87006, 3ZC5C2A88004, 3ZC5C2A88007, 3ZC5C2A74003, 3ZC5C2A75010, 3ZC5C2A75011, 3ZC5C2A76003, 3ZC5C2A76005, 3ZC5C2A76012, 3ZC5C2A76020, 3ZC5C2A78001, 3ZC5C2A7C003, 3ZC5C2A81010, 3ZC5C2A84005, 3ZC5C2A84012, 3ZC5C2A71002, 3ZC5C2A71004, 3ZC5C2A73007, 3ZC5C2A74009, 3ZC5C2A76023, 3ZC5C2A7C002, 3ZC5C2A73015, , Model Numbers: CH-200, UDI codes: N/A, Serial Numbers:, 0162M46304, 0162M47002, 0162M48002, 0162M48801, 0162M48902, 0162M48903, 3ZC5C2A21005, 3ZC5C2A4B008, 3ZC5C2A52005, 3ZC5C2A6B011, 0162M46101, 0162M46104, 0162M47505, 0162M47508, 0162M48702, 0162M49006, 0162M49203, 0162M49501, 0162M50007, 0262M49709, 0262M46103, 3ZC5C2A41006, 0362M46501, 0262M48307, 0362M46710, 0362M48206, 0362M49902, 0462M45303, 0462M48001, 0462M48209, 0462M48302, 0462M48902, 3ZC5C2A16003, 3ZC5C2A21006, 3ZC5C2A23017, 3ZC5C2A23019, 3ZC5C2A28011, 3ZC5C2A31002, 3ZC5C2A32006, 3ZC5C2A34003, 3ZC5C2A35018, 3ZC5C2A38016, 3ZC5C2A39004, 3ZC5C2A39005, 3ZC5C2A3A009, 3ZC5C2A3C010, 3ZC5C2A41001, 3ZC5C2A41002, 3ZC5C2A41003, 3ZC5C2A44006, 3ZC5C2A46006, 3ZC5C2A46007, 3ZC5C2A4C009, 3ZC5C2A53011, 3ZC5C2A53013, 3ZC5C2A5C008, 3ZC5C2A5C009, 3ZC5C2A62003, 3ZC5C2A62004, 3ZC5C2A62008, 3ZC5C2A63011, 3ZC5C2A67010, 3ZC5C2A68002, 3ZC5C2A6C003, 3ZC5C2B16001, 3ZC5C2B31001, 0162M45102, 0162M45124, 0162M45127, 0162M45129, 0162M45130, 0162M45131, 0162M45134, 0162M45135, 0162M45137, 0162M45138, 0162M45144, 0162M45145, 0162M46105, 0162M46106, 0162M46109, 0162M46110, 0162M46210, 0162M46301, 0162M46305, 0162M46605, 0162M46606, 0162M46608, 0162M46708, 0162M47003, 0162M47004, 0162M47306, 0162M47308, 0162M47402, 0162M47404, 0162M47406, 0162M47407, 0162M47509, 0162M47902, 0162M47905, 0162M47909, 0162M48003, 0162M48510, 0162M48802, 0162M48907, 0162M48909, 0162M49005, 0162M49704, 0262M45502, 0262M45503, 0262M45504, 0262M45703, 0262M45704, 0262M45705, 0262M45706, 0262M45710, 0262M45803, 0262M46007, 0262M47207, 0262M47209, 0262M47406, 0262M46104, 0262M47205, 0462M49105, 0262M47505, 0262M47506, 0262M47706, 0262M47707, 0262M47806, 3ZC5C2A45017, 0262M48003, 0362M49305, 0262M48101, 3ZC5C2A2B014, 3ZC5C2A37005, 3ZC5C2A53008, 3ZC5C2A53007, 0262M48107, 0262M48108, 0262M48109, 3ZC5C2A48015, 0262M48208, 0262M48301, 0262M48305, 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3ZC5C2A62005, 0462M49006, 3ZC5C2A16010, 3ZC5C2A51005, 3ZC5C2A46008, 3ZC5C2B2B003, 0362M45401, 0362M46607, 3ZC5C2A2C010, 0262M48202, 0362M49306, 3ZC5C2A0A007, 0462M49609, 0362M45704, 0462M47802, 0462M47803, 3ZC5C2A38005, 3ZC5C2A2C012, 0362M47104, 0362M49304, 3ZC5C2A47008, 3ZC5C2A57017, 3ZC5C2A64017, 3ZC5C2A6C014, 3ZC5C2A25006, 3ZC5C2A44013, 3ZC5C2A1C008, 3ZC5C2A57015, 3ZC5C2A2C004, 3ZC5C2A27002, 3ZC5C2A19003, 3ZC5C2A49009, 3ZC5C2A12002, 0462M47101, 0362M47908, 0462M47103, 0262M49207, 0262M49209, 0262M49906, 0462M47809, 0462M47704, 0462M46102, 3ZC5C2A21001, 3ZC5C2A61004, 0462M47603, 3ZC5C2A2C002, 0362M46201, 0362M49707, 0362M49906, 0462M45304, 0562M45302, 3ZC5C2A38003, 0462M46605, 0462M47705, 3ZC5C2A46012, 3ZC5C2A4B010, 3ZC5C2A5B009, 0462M47801, 0262M49206, 0462M47901, 0262M49706, 0262M49907, 0362M45703, 0462M48206, 0362M46709, 0262M49007, 0362M45405, 0362M45410, 0362M47201, 3ZC5C2A66012, 3ZC5C2A49005, 0462M48905, 3ZC5C2A5B008, 3ZC5C2A5A001, 0362M46703, 0362M46706, 3ZC5C2A12007, 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3ZC5C2B18001, 3ZC5C2B21001, 3ZC5C2B2B001, 3ZC5C2B2C001, 0162M45123, 0162M46401, 0162M47507, 0162M47907, 0162M48807, 0162M48904, 0162M48906, 0162M50005, 0262M47208, 0262M47503, 0262M48205, 0262M48304, 0362M46110, 0462M47605, 0462M47703, 0462M48208, 0362M47805, 3ZC5C2A24007, 3ZC5C2A23016, 3ZC5C2A18001, 3ZC5C2A23013, 3ZC5C2A35020, 3ZC5C2A5C011, 0562M45603, 0562M45504, 0462M45907, 0462M46402, 3ZC5C2A16005, 3ZC5C2A14003, 3ZC5C2A24001, 3ZC5C2A4C016, 3ZC5C2A5C001, 3ZC5C2A48011, 3ZC5C2A1A005, 3ZC5C2A64020, 3ZC5C2A65007, 3ZC5C2A65008, 3ZC5C2A65009, 3ZC5C2A65011, 3ZC5C2A44007, 0362M47801, 0462M49408, 3ZC5C2A55006, 3ZC5C2A55007, 3ZC5C2A55009, 3ZC5C2A21014, 0462M48003, 0362M47409, 0462M50001, 3ZC5C2A2B016, 3ZC5C2A13003, 3ZC5C2A2B017, 3ZC5C2A2C005, 0462M48303, 3ZC5C2A17006, 3ZC5C2A23009, 3ZC5C2A2C009, 3ZC5C2A21008, 3ZC5C2A21009, 3ZC5C2A33007, 3ZC5C2A36002, 0262M49909, 0362M47408, 0362M47406, 0462M49610, 3ZC5C2A3B001, 3ZC5C2A18011, 3ZC5C2A19001, 3ZC5C2A5A015, 0262M49904, 0562M45306, 3ZC5C2A11006, 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Recall # Classification Product Date
Z-0316-2025 Class II SONIALVISION G4 is a multi-purpose X-ray R/F sy... Sep 6, 2024
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Z-0317-2025 Class II The FLUOROspeed is intended to be used as a uni... Sep 6, 2024
Z-1292-2024 Class II Shimadzu, Trinias, Digital Angiography System Jan 29, 2024
Z-2270-2023 Class II Over-Head Ceiling Tube Support, CH-200, CH-200M... Apr 10, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.