Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems T

Summary

The FDA issued a Class II for Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, S by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION. Reason: 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 .

Details

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.

Lot/Code Info: 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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0262M44301, 0262M44302, 0262M44303, 0262M44408, 0362M40801, 0362M40802, 0362M40803, 0362M41407, 0362M41409, 0362M42404, 0462M40103, 0462M41202, 0562M42806, 0662M40808, 3ZC5C160C006, 3ZC5C1612002, 3ZC5C1613002, 3ZC5C1615001, 3ZC5C161B003, 3ZC5C1623002, 3ZC5C1631002, 3ZC5C1643002, 3ZC5C1643003, 3ZC5C1643005, 41E733E63001, 41E733E67001, 41E733E67005, 41E733E6B001, 41E733E6B009, 0462M40102, 3ZC5C160C004, 41E733E67004, 3ZC5C1645004, 3ZC5C162A002, 0462M41201, 3ZC5C1616004, 3ZC5C162B001, 3ZC5C1636001, 3ZC5C160C003, 0662M40809, 3ZC5C1616001, 3ZC5C1654001, 0462M41602, 3ZC5C1629005, 3ZC5C161A001, 0462M40202, 3ZC5C162A004, 0362M40510, 0462M44204, 3ZC5C1646002, 0162M43015, 0162M43016, 0162M43218, 0162M43614, 0262M40507, 0262M40710, 0262M42604, 0362M42405, 0562M43906, 3ZC5C164C002, 0362M43603, 3ZC5C1612004, 41E733E69005, 3ZC5C161A002, 3ZC5C1635001, 3ZC5C1629003, 3ZC5C1623003, 3ZC5C1629001, 3ZC5C1616003, 0462M42002, 3ZC5C1632002, 0162M43017, 0162M43612, 0262M40508, 0262M40607, 0262M43602, 0462M41701, 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.

Quantity Affected: 1,766 devices

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-10-16

Company