Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M recallZ-0499-2026 · Shimadzu Corporation Medical Systems Division · initiated Oct 16, 2025
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
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 root cause category: Device Design
What the company is doing
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
Recall details
- Recall number
- Z-0499-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 16, 2025
- Posted by the FDA
- Nov 13, 2025
- Recalling firm
- Shimadzu Corporation Medical Systems Division
- Quantity
- 1,766 devices
- Product code
- IYB
- 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.
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.
Code information (models, lots, serial numbers)
Show the full code information (24k characters)
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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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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3ZC5C2A41010, 3ZC5C2A41012, 3ZC5C2A41009, 3ZC5C2A41011, 3ZC5C2A44003, 3ZC5C2A44002, 3ZC5C2A31010, 3ZC5C2A63016, 3ZC5C2A63018, 3ZC5C2A64004, 3ZC5C2A52009, 3ZC5C2A22015, 3ZC5C2A33006, 3ZC5C2A0B004, 3ZC5C2A58002, 0362M49506, 3ZC5C2A38007, 3ZC5C2A3A001, 0362M46601, 0362M46704, 3ZC5C2A1B009, 0562M45303, 3ZC5C2A22003, 3ZC5C2A48018, 3ZC5C2A1B014, 3ZC5C2A1B008, 0362M47804, 0362M47905, 3ZC5C2A4A005, 3ZC5C2A48010, 3ZC5C2A4B004, 3ZC5C2A2B010, 3ZC5C2A31012, 3ZC5C2A32001, 3ZC5C2A34001, 3ZC5C2A45011, 3ZC5C2A47002, 3ZC5C2A54004, 3ZC5C2A23010, 3ZC5C2A48004, 3ZC5C2A65006, 3ZC5C2A35017, 3ZC5C2A69009, 0262M48303, 3ZC5C2A47004, 3ZC5C2A24010, 0262M49002, 0462M47707, 0462M47708, 3ZC5C2A63002, 3ZC5C2A48022, 3ZC5C2A2B003, 0462M46302, 3ZC5C2A47016, 0462M49007, 0362M49301, 3ZC5C2A48007, 3ZC5C2A21002, 3ZC5C2A38012, 0262M46702, 0262M48103, 0262M48302 Model Numbers: CH-200M, UDI codes: 04540217050826, Serial Numbers:, 41E733E74005, 41E733E72003, 41E733E85002, 41E733E86001, 41E733E86002, 41E733E86003, 41E733E86004, 41E733E88001, 41E733E72001, 41E733E72002, 41E733E72005, 41E733E74001, 41E733E74003, 41E733E74004, 41E733E85001, 41E733E88002, 41E733E88003, 41E733E72004, 41E733E86005, 41E733E74002, 41E733E88004 Model Numbers: CH-200M, UDI codes: N/A, Serial Numbers:, 0262M42603, 0362M44102, 0462M43402, 0462M43403, 0562M43907, 0362M44701, 41E733E67002, 41E733E64004, 41E733E65001, 41E733E63005, 3ZC5C1661001, 41E733E64001, 41E733E6B004, 0462M40101, 3ZC5C160C005, 0662M41305, 0562M42808, 3ZC5C1653001, 3ZC5C1652002, 0662M40807, 0662M40806, 0662M40401, 0362M44502, 0462M43404, 3ZC5C1632004, 0262M40510, 3ZC5C1617001, 0462M45001, 0462M45003, 0562M44901, 3ZC5C1645001, 3ZC5C1645002, 3ZC5C1612005, 3ZC5C162C001, 3ZC5C162A001, 0662M41303, 0562M42805, 3ZC5C1622001, 0562M40701, 3ZC5C160C007, 3ZC5C1635002, 0362M44702, 0362M44703, 3ZC5C162B002, 0262M44906, 0162M43610, 0162M43613, 0162M43618, 0162M43619, 0162M43620, 0162M43916, 0162M44409, 0162M44509, 0262M40509, 0262M40610, 0262M41609, 0262M43904, 0262M44301, 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0462M43202, 0462M45002, 0562M40702, 0562M43110, 3ZC5C1638001, 3ZC5C164A002, 3ZC5C1655002, 41E733E6B003, 3ZC5C164A001, 41E733E64003, 3ZC5C161B001, 3ZC5C1625001, 3ZC5C1648001, 0362M44501, 3ZC5C1659001, 41E733E63003, 3ZC5C1652001, 3ZC5C1641001, 0362M44704, 3ZC5C1631001, 3ZC5C160C001, 3ZC5C1612003, 0162M42920, 0162M43611, 0162M43616, 0262M40506, 0262M42801, 0262M42901, 0462M41204, 0462M43001, 0462M44202, 3ZC5C1629004, 3ZC5C1632003, 3ZC5C1633001, 41E733E6A001, 41E733E6B002, 41E733E69002, 0562M42608, 41E733E64002, 3ZC5C164C001, 0262M44403, 0362M43601, 3ZC5C1637001, 3ZC5C1637002, 41E733E63002, 3ZC5C162C002, 3ZC5C162A003, 0462M41203, 0362M44104, 0462M41601, 0262M44205, 0462M40201, 0462M44203, 0262M44409, 0462M42001, 0362M41408, 0662M41304, 0162M43615, 0262M43202, 0262M43510, 0262M44407, 3ZC5C1632001, 3ZC5C1628002, 0462M43002, 0162M43617, 0462M42402, 3ZC5C1616002, 0562M42804, 3ZC5C1612006, 3ZC5C1641002, 3ZC5C1623004, 3ZC5C1637003, 3ZC5C161B002, 3ZC5C1612008, 0562M42807, 0362M43002, 0262M42709, 0262M44304, 0262M44204, 0362M44905, 3ZC5C1612007, 3ZC5C1655001, 3ZC5C1661002, 41E733E69004, 0462M43401, 0462M43406, 0462M42104, 0462M43405, 0462M44002, 0462M45004, 0462M43201, 0162M43518, 0162M44510, 0262M43905, 3ZC5C1633002, 0362M41101, 0362M42303, 0362M42403, 0362M43604, 0362M44103, 3ZC5C1636002, 3ZC5C1629002, 3ZC5C1643004, 3ZC5C1613001, 0462M43803, 0462M44205, 0562M41105, 0662M40601, 3ZC5C1612001, 3ZC5C1623001, 0562M42803, 41E733E63004, 41E733E69001, 3ZC5C163A001, 3ZC5C1645003, 3ZC5C1648002, 0462M42105, 41E733E67003, 0462M41205, 3ZC5C1717001, 3ZC5C1628001, 41E733E6B006, 0262M44203, 0262M44807, 41E733E6B005, 41E733E6B007, 41E733E6B008.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- CH-200 503-58100-26Shimadzu Corporation · Tube Mount, X-Ray, Diagnostic1 recall0 reports
- CH-200M 503-79470-06Shimadzu 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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