Z-0499-2026Class II
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed...
Shimadzu Corporation Medical Systems Division / initiated 2025-10-16 / Open, Classified / root cause: design
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION began a recall of 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... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0499-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Shimadzu Corporation Medical Systems Division
- 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.
- Product code
- IYB Tube Mount, X-Ray, Diagnostic
- 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.
- Root cause tag
- design
- FDA root 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.
- Product codes and lots
- 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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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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0499-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.