Class 2 Device Recall Ceiling Type Xray Tube Support

• Date Initiated by Firm: October 16, 2025
• Date Posted: November 13, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0499-2026
• Recall Event ID: 97365
• Product Classification: Tube mount, x-ray, diagnostic - Product Code IYB
• Product: 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.
• 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, 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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, 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• FEI Number: 3002808139
• Recalling Firm/ Manufacturer: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION; Nishinokyo Kuwabara -Cho; Nakagyo-Ku; 1; Kyoto Japan
• For Additional Information Contact: Mr. Johnny Goossens; 310-217-8855 Ext. 130
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: On 10/16/2025, the firm emailed an "Urgent: Voluntary Medical Device Recall Notice" to customers informing them that, the firm has identified potential problems with the Ceiling Tube Support that consists of an X-ray Tube holder with has a rotation mechanism. There is the potential for rotation shaft cracking due to periodic movements. If the cracks grow, the retaining shaft may eventually break. The mechanical stopper is equipped to prevent X-ray tube assembly from coming off even if the retaining shaft breaks. It may not work effectively only if the shaft breaks while being operated toward front while lifting. X-ray tube assembly weighs 40 kg and if it were to fall off and contact the patient or the operator, it could cause critical injuries. Customer are instructed to: - Perform the daily inspection described in the CH-200/CH-200M operation manual to check for wobbles or shakes, misalignment of the light irradiation position, etc. If any abnormality is found, discontinue use and contact our service provider. When rotating the X-ray tube unit, do not hit the stopper at the end. If the stopper is hit hard, in the unlikely event that a crack has already occurred, a large impact may be applied, and the growth of the crack may be accelerated. In the case of electric rotation, it is controlled by software and does not hit the stopper. - Do not rotate the X-ray tube over or near the patient. For questions - Shimadzu Medical Systems National Technical Support: Toll Free: (844)487-2767 Available 8:00 to 5:00 PM, Monday - Friday
• Quantity in Commerce: 1,766 devices
• Distribution: 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.
• 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.