Class 2 Device Recall OverHead Ceiling Tube Support, CH200, CH200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision

• Date Initiated by Firm: April 10, 2023
• Date Posted: July 31, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2270-2023
• Recall Event ID: 92391
• Product Classification: Tube mount, x-ray, diagnostic - Product Code IYB
• Product: 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
• 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, 0462M46401, 0462M46402, 0462M46403, 0462M46605, 0462M46606, 0462M46607, 0462M46608, 0462M47101, 0462M47103, 0462M47409, 0462M47601, 0462M47603, 0462M47703, 0462M47704, 0462M47705, 0462M47801, 0462M47802, 0462M47803, 0462M47809, 0462M47810, 0462M47901, 0462M47902, 0462M48003, 0462M48206, 0462M48207, 0462M48208, 0462M48301, 0462M48304, 0462M48905, 0462M49006, 0462M49104, 0462M49105, 0462M49210, 0462M49606, 0462M49607, 0462M49609, 0462M49610, 0462M50001, 0462M50002, 0462M50003, 0562M45302, 0562M45306, 0562M45504, 0562M45603, 0562M45606, 0562M45607, 0562M45608, 0562M46301, 3ZC5C2A0A002, 3ZC5C2A0A003, 3ZC5C2A0A006, 3ZC5C2A0A007, 3ZC5C2A0A009, 3ZC5C2A0A00A, 3ZC5C2A0B003, 3ZC5C2A0C005, 3ZC5C2A11006, 3ZC5C2A1100A, 3ZC5C2A12002, 3ZC5C2A12005, 3ZC5C2A12007, 3ZC5C2A13003, 3ZC5C2A13004, 3ZC5C2A13006, 3ZC5C2A14001, 3ZC5C2A14007, 3ZC5C2A14009, 3ZC5C2A16006, 3ZC5C2A16007, 3ZC5C2A16008, 3ZC5C2A16009, 3ZC5C2A16010, 3ZC5C2A17005, 3ZC5C2A18008, 3ZC5C2A19003, 3ZC5C2A19004, 3ZC5C2A1A002.3ZC5C2A1A003, 3ZC5C2A1A004, 3ZC5C2A1A005, 3ZC5C2A1C001, 3ZC5C2A1C002, 3ZC5C2A1C004, 3ZC5C2A1C006, 3ZC5C2A1C008, 3ZC5C2A1C009, 3ZC5C2A21001, 3ZC5C2A21013, 3ZC5C2A21014, 3ZC5C2A22002, 3ZC5C2A22016, 3ZC5C2A22017, 3ZC5C2A23001, 3ZC5C2A23003, 3ZC5C2A24001, 3ZC5C2A24002, 3ZC5C2A24012, 3ZC5C2A25004, 3ZC5C2A25006, 3ZC5C2A26002, 3ZC5C2A26003, 3ZC5C2A27001, 3ZC5C2A27002, 3ZC5C2A28006, 3ZC5C2A28007, 3ZC5C2A2B009, 3ZC5C2A2B014, 3ZC5C2A2B015, 3ZC5C2A2B016, 3ZC5C2A2B017, 3ZC5C2A2C001, 3ZC5C2A2C002, 3ZC5C2A2C003, 3ZC5C2A2C004, 3ZC5C2A2C005, 3ZC5C2A2C010, 3ZC5C2A2C012, 3ZC5C2A31003, 3ZC5C2A31004, 3ZC5C2A32005, 3ZC5C2A33004, 3ZC5C2A33008, 3ZC5C2A34002, 3ZC5C2A35019, 3ZC5C2A36003, 3ZC5C2A36004, 3ZC5C2A36006, 3ZC5C2A37005, 3ZC5C2A37012, 3ZC5C2A38003, 3ZC5C2A38004, 3ZC5C2A38005, 3ZC5C2A3B001, 3ZC5C2A43003, 3ZC5C2A43006, 3ZC5C2A44013, 3ZC5C2A45015, 3ZC5C2A45016, 3ZC5C2A45017, 3ZC5C2A46008, 3ZC5C2A46012, 3ZC5C2A47006, 3ZC5C2A47008, 3ZC5C2A47010, 3ZC5C2A48005, 3ZC5C2A48015, 3ZC5C2A48020, 3ZC5C2A49001, 3ZC5C2A49005, 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, 3ZC5C2A19001, 3ZC5C2A21008, 3ZC5C2A21009, 3ZC5C2A22004, 3ZC5C2A23009, 3ZC5C2A23013, 3ZC5C2A23015, 3ZC5C2A23016, 3ZC5C2A24007, 3ZC5C2A28009, 3ZC5C2A2C009, 3ZC5C2A33005, 3ZC5C2A33007, 3ZC5C2A35020, 3ZC5C2A36002, 3ZC5C2A37009, 3ZC5C2A37011, 3ZC5C2A39002, 3ZC5C2A43005, 3ZC5C2A44007, 3ZC5C2A48011, 3ZC5C2A49014, 3ZC5C2A4C008, 3ZC5C2A4C016, 3ZC5C2A54008, 3ZC5C2A55006, 3ZC5C2A55007, 3ZC5C2A55009, 3ZC5C2A55010, 3ZC5C2A5A006, 3ZC5C2A5A015, 3ZC5C2A5C001, 3ZC5C2A5C002, 3ZC5C2A61008, 3ZC5C2A64005, 3ZC5C2A6C012, 3ZC5C2A6C013, 3ZC5C2A73012, 3ZC5C2A73013, 3ZC5C2A73014, 3ZC5C2A76006, 3ZC5C2A76019, 3ZC5C2A76027, 3ZC5C2A77003, 3ZC5C2A81002, 3ZC5C2A81004, 3ZC5C2A85017, 3ZC5C2A85019, 3ZC5C2A86010, 3ZC5C2A88008, 3ZC5C2A8A006, 3ZC5C2A8A007, 3ZC5C2A8A010, 3ZC5C2A8C004, 3ZC5C2A91006, 3ZC5C2A94004, 3ZC5C2A95007, 3ZC5C2B27001, 3ZC5C2B37001, 0162M45139, 0162M45140, 0162M46206, 0162M46302, 0162M47005, 0162M47309, 0162M47401, 0162M47601, 0162M48001, 0162M48910, 0162M50003, 0162M50004, 0262M45707, 0262M46009, 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• Recalling Firm/ Manufacturer: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION; Nishinokyo Kuwabara -Cho; Nakagyo-Ku; 1; Kyoto Japan
• For Additional Information Contact: Johnny Goossens; 310-217-8855 Ext. 130
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: On 4/10/23, recall notices were emailed to customers who were asked to do the following: 1)The Tube Column Assembly is secured by eight fixing bolts located at the base of the assembly. If while using the system, you observe loose, or missing bolts then please discontinue use of the system and call your authorized Service Provider. 2) Schedule a time with their Distributer to have their system updated. 3) Post the notice within their facility so that all users are aware of how to avoid this issue until the corrective actions has been completed. 4) Complete and return the Customer Acknowledgement and Receipt of Letter form to drodriguez@shimadzu-usa.com The National Technical Support phone number was provided: 844-487-2767
• Quantity in Commerce: 1836
• Distribution: U.S. Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.