Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Visi...
FDA Device Recall #Z-2270-2023 — Class II — April 10, 2023
Recall Summary
| Recall Number | Z-2270-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 10, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Location | Kyoto, N/A |
| Product Type | Devices |
| Quantity | 1836 |
Product Description
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
Reason for Recall
Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling.
Distribution Pattern
U.S. Nationwide distribution.
Lot / Code Information
All manufactured prior to August 1,2019. REF/UDI-DI/Serial Numbers: CH-200/04540217031436/0162M46304, 0162M48002, 0162M48801, 0162M48902, 0162M48903, 3ZC5C2A21005, 3ZC5C2A4B008, 3ZC5C2A52005, 3ZC5C2A6B011, 3ZC5C2A84014, 3ZC5C2A85003, 3ZC5C2A88019, 3ZC5C2A91005, 3ZC5C2A92004, 0162M46101, 0162M46104, 0162M47505, 0162M47508, 0162M48702, 0162M49006, 0162M49203, 0162M49501, 0162M50007, 0262M46103, 0262M48307, 0262M49709, 0362M46501, 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, 3ZC5C2A41006, 3ZC5C2A44006, 3ZC5C2A46006, 3ZC5C2A46007, 3ZC5C2A4C009, 3ZC5C2A53011, 3ZC5C2A53013, 3ZC5C2A5C008, 3ZC5C2A5C009, 3ZC5C2A62003, 3ZC5C2A62004, 3ZC5C2A62008, 3ZC5C2A63011, 3ZC5C2A67010, 3ZC5C2A68002, 3ZC5C2A6C003, 3ZC5C2A75012, 3ZC5C2A76002, 3ZC5C2A76016, 3ZC5C2A76026, 3ZC5C2A77013, 3ZC5C2A79003, 3ZC5C2A84008, 3ZC5C2A86013, 3ZC5C2A8A012, 3ZC5C2B16001, 3ZC5C2B31001, LZC5C5196031, 0162M45119, 0162M45123, 0162M45124, 0162M45127, 0162M45129, 0162M45131, 0162M45134, 0162M45135, 0162M45137, 0162M45138, 0162M45144, 0162M45145, 0162M46105, 0162M46106, 0162M46109, 0162M46110, 0162M46210, 0162M46606, 0162M46608, 0162M46708, 0162M47003, 0162M47004, 0162M47306, 0162M47308, 0162M47402, 0162M47404, 0162M47406, 0162M47407, 0162M47507, 0162M47509, 0162M47902, 0162M47905, 0162M47909, 0162M48510, 0162M48802, 0162M48807, 0162M48904, 0162M48907, 0162M48909, 0162M49005, 0162M49704, 0262M45502, 0262M45503, 0262M45504, 0262M45703, 0262M45704, 0262M45705, 0262M45706, 0262M45710, 0262M45803, 0262M46007, 0262M46104, 0262M47205, 0262M47207, 0262M47209, 0262M47406, 0262M47408, 0262M47503, 0262M47504, 0262M47506, 0262M47706, 0262M47707, 0262M47806, 0262M48003, 0262M48101, 0262M48106, 0262M48107, 0262M48108, 0262M48109, 0262M48202, 0262M48205, 0262M48208, 0262M48301, 0262M48305, 0262M48306, 0262M48804, 0262M48806, 0262M49001, 0262M49006, 0262M49007, 0262M49203, 0262M49204, 0262M49206, 0262M49207, 0262M49209, 0262M49210, 0262M49701, 0262M49702, 0262M49706, 0262M49808, 0262M49906, 0262M49907, 0262M49909, 0362M45401, 0362M45403, 0362M45404, 0362M45405, 0362M45410, 0362M45703, 0362M45704, 0362M45705, 0362M46102, 0362M46103, 0362M46108, 0362M46110, 0362M46201, 0362M46603, 0362M46604, 0362M46607, 0362M46703, 0362M46706, 0362M46707, 0362M46708, 0362M46709, 0362M47104, 0362M47108, 0362M47109, 0362M47201, 0362M47202, 0362M47207, 0362M47407, 0362M47409, 0362M47410, 0362M47501, 0362M47502, 0362M47507, 0362M47802, 0362M47902, 0362M47903, 0362M47908, 0362M48203, 0362M48204, 0362M48207, 0362M48302, 0362M48304, 0362M48305, 0362M48701, 0362M49304, 0362M49305, 0362M49306, 0362M49404, 0362M49405, 0362M49407, 0362M49408, 0362M49707, 0362M49709, 0362M49904, 0362M49905, 0362M49906, 0362M50003, 0362M50005, 0462M45304, 0462M45907, 0462M46101, 0462M46102, 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3ZC5C2A49006, 3ZC5C2A49007, 3ZC5C2A49009, 3ZC5C2A4A003, 3ZC5C2A4A008, 3ZC5C2A4B002, 3ZC5C2A4B007, 3ZC5C2A4B009, 3ZC5C2A4B010, 3ZC5C2A51005, 3ZC5C2A53007, 3ZC5C2A53008, 3ZC5C2A54007, 3ZC5C2A55004, 3ZC5C2A56003, 3ZC5C2A56008, 3ZC5C2A57010, 3ZC5C2A57015, 3ZC5C2A57017, 3ZC5C2A5A001, 3ZC5C2A5B005, 3ZC5C2A5B008, 3ZC5C2A5B009, 3ZC5C2A5B010, 3ZC5C2A5C010, 3ZC5C2A5C011, 3ZC5C2A61004, 3ZC5C2A62005, 3ZC5C2A63009, 3ZC5C2A63010, 3ZC5C2A64006, 3ZC5C2A64008, 3ZC5C2A64017, 3ZC5C2A64020, 3ZC5C2A65007, 3ZC5C2A65008, 3ZC5C2A65009, 3ZC5C2A65011, 3ZC5C2A66006, 3ZC5C2A66011, 3ZC5C2A66012, 3ZC5C2A66013, 3ZC5C2A67006, 3ZC5C2A6A001, 3ZC5C2A6A007, 3ZC5C2A6A008, 3ZC5C2A6B004, 3ZC5C2A6B005, 3ZC5C2A6C014, 3ZC5C2A71003, 3ZC5C2A73001, 3ZC5C2A73006, 3ZC5C2A74004, 3ZC5C2A75002, 3ZC5C2A75005, 3ZC5C2A75006, 3ZC5C2A75007, 3ZC5C2A76010, 3ZC5C2A76013, 3ZC5C2A76018, 3ZC5C2A76022, 3ZC5C2A77010, 3ZC5C2A77011, 3ZC5C2A77012, 3ZC5C2A77014, 3ZC5C2A77023, 3ZC5C2A78002, 3ZC5C2A78003, 3ZC5C2A79001, 3ZC5C2A79002, 3ZC5C2A7A001, 3ZC5C2A7A002, 3ZC5C2A7B001, 3ZC5C2A7B002, 3ZC5C2A7B015, 3ZC5C2A7B019, 3ZC5C2A7C006, 3ZC5C2A7C007, 3ZC5C2A7C016, 3ZC5C2A81001, 3ZC5C2A82004, 3ZC5C2A83002, 3ZC5C2A84002, 3ZC5C2A85005, 3ZC5C2A85010, 3ZC5C2A85015, 3ZC5C2A85016, 3ZC5C2A85018, 3ZC5C2A86002, 3ZC5C2A86003, 3ZC5C2A86004, 3ZC5C2A86009, 3ZC5C2A86011, 3ZC5C2A87008, 3ZC5C2A87010, 3ZC5C2A88003, 3ZC5C2A88005, 3ZC5C2A89001, 3ZC5C2A8A001, 3ZC5C2A8A004, 3ZC5C2A8A005, 3ZC5C2A8B006, 3ZC5C2A8B007, 3ZC5C2A8B009, 3ZC5C2A8C005, 3ZC5C2A92002, 3ZC5C2A93004, 3ZC5C2A94001, 3ZC5C2A94002, 3ZC5C2B12001, 3ZC5C2B18001, 3ZC5C2B21001, 3ZC5C2B22001, 3ZC5C2B28001, 3ZC5C2B2B001, 3ZC5C2B2B003, 3ZC5C2B2C001, LZC5C5196017, LZC5C5197010, 0162M47907, 0162M48906, 0162M50005, 0262M47208, 0262M48304, 0262M49904, 0262M49910, 0362M47406, 0362M47408, 0362M47801, 0362M47805, 0362M48301, 0362M49801, 0462M47604, 0462M47605, 0462M48303, 0462M49408, 3ZC5C2A14003, 3ZC5C2A16001, 3ZC5C2A16002, 3ZC5C2A16005, 3ZC5C2A17006, 3ZC5C2A18001, 3ZC5C2A18009, 3ZC5C2A18011, 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41E733E86003, 41E733E86004, 41E733E88001, 0162M43015, 0162M43016, 0162M43218, 0162M43614, 0262M40507, 0262M40710, 0262M42604, 0362M40510, 0362M42405, 0462M40102, 0462M41201, 0462M41602, 0462M44204, 0562M43906, 0662M40809, 3ZC5C160C003, 3ZC5C160C004, 3ZC5C1616001, 3ZC5C1616004, 3ZC5C161A001, 3ZC5C1629005, 3ZC5C162A002, 3ZC5C162A004, 3ZC5C162B001, 3ZC5C1636001, 3ZC5C1645004, 3ZC5C1646002, 3ZC5C164C002, 3ZC5C1654001, 41E733E67004, 41E733E72001, 41E733E72002, 41E733E72005, 41E733E74001, 41E733E74003, 0162M43017, 0162M43612, 0262M40508, 0262M40607, 0262M43602, 0362M43603, 0462M41701, 0462M42002, 0462M43202, 0462M45002, 0562M40702, 0562M43110, 3ZC5C1612004, 3ZC5C1616003, 3ZC5C161A002, 3ZC5C1623003, 3ZC5C1629003, 3ZC5C1632002, 3ZC5C1635001, 3ZC5C1638001, 3ZC5C164A002, 3ZC5C1655002, 41E733E69005, 41E733E6B003, 41E733E74004, 41E733E85001, 0162M43615, 0262M43202, 0262M43510, 0262M44407, 0262M44409, 0362M41408, 0462M42001, 0662M41304, 0162M42920, 0162M43611, 0162M43616, 0262M40506, 0262M42801, 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Other Recalls from SHIMADZU CORPORATION MEDICAL SYSTEMS ...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0499-2026 | Class II | Ceiling Type X-Ray Tube Support Models CH-200 a... | Oct 16, 2025 |
| Z-0316-2025 | Class II | SONIALVISION G4 is a multi-purpose X-ray R/F sy... | Sep 6, 2024 |
| Z-0139-2025 | Class II | Trinias unity, Digital Angiography System with ... | Sep 6, 2024 |
| 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 |
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.