SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: 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 un

Hazard

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.

Details from the source

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. Distribution: U.S. Nationwide distribution. Quantity: 1836 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, 0162M4

UPC codes

04540217031436, 04540217062782

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.