Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with… recallZ-2270-2023 · Shimadzu Corporation Medical Systems Division · initiated Apr 10, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Shimadzu Corporation Medical Systems Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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 [email protected] The National Technical Support phone number was provided: 844-487-2767
Recall details
- Recall number
- Z-2270-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 10, 2023
- Posted by the FDA
- Jul 31, 2023
- Recalling firm
- Shimadzu Corporation Medical Systems Division
- Quantity
- 1836
- Product code
- IYB
- Distribution
- U.S. Nationwide distribution.
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
Code information (models, lots, serial numbers)
Show the full code information (24k characters)
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, 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Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- CH-200 503-58100-34Shimadzu Corporation · Tube Mount, X-Ray, Diagnostic1 recall0 reports
- CH-200M 563-58100-47Shimadzu Corporation · Tube Mount, X-Ray, Diagnostic1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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