Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4

Summary

The FDA issued a Class II for Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION. Reason: 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, a.

Details

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

Lot/Code Info: 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, 3ZC5C2A76026, 3ZC5C2A77013, 3ZC5C2A79003, 3ZC5C2A84008, 3ZC5C2A86013, 3ZC5C2A8A012, 3ZC5C2B16001, 3ZC5C2B31001, LZC5C5196031, 0162M45119, 0162M45123, 0162M45124, 0162M45127, 0162M45129, 0162M45131, 0162M45134, 0162M45135, 0162M45137, 0162M45138, 0162M45144, 0162M45145, 0162M46105, 0162M46106, 0162M46109, 0162M46110, 0162M46210, 0162M46606, 0162M46608, 0162M46708, 0162M47003, 0162M47004, 0162M47306, 0162M47308, 0162M47402, 0162M47404, 0162M47406, 0162M47407, 0162M47507, 0162M47509, 0162M47902, 0162M47905, 0162M47909, 0162M48510, 0162M48802, 0162M48807, 0162M48904, 0162M48907, 0162M48909, 0162M49005, 0162M49704, 0262M45502, 0262M45503, 0262M45504, 0262M45703, 0262M45704, 0262M45705, 0262M45706, 0262M45710, 0262M45803, 0262M46007, 0262M46104, 0262M47205, 0262M47207, 0262M47209, 0262M47406, 0262M47408, 0262M47503, 0262M47504, 0262M47506, 0262M47706, 0262M47707, 0262M47806, 0262M48003, 0262M48101, 0262M48106, 0262M48107, 0262M48108, 0262M48109, 0262M48202, 0262M48205, 0262M48208, 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Quantity Affected: 1836

Reason for Recall

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-04-10

Company