Home › Device types › IYB
Tube Mount, X-Ray, Diagnostic
FDA product code IYB · Class 1 · Radiology
95
Registered devices
85
Adverse events
13
Recalls
40
510(k) clearances
Devices with this code
DRGEM — DRGEM CorporationSEDECAL — SEDECALQS-550-MAT — CARESTREAM HEALTH, INC.Summit — SUMMIT INDUSTRIES, LLCCH-200 — SHIMADZU CORPORATIONFH-21HR — SHIMADZU CORPORATIONPaxis 100 — Pausch, L.L.C.FH-21HR — SHIMADZU CORPORATIONCirrus — Pausch, L.L.C.Del Medical, Inc. — Del Medical, Inc.DRGEM — DRGEM CorporationDel Medical, Inc. — Del Medical, Inc.DRGEM — DRGEM CorporationDRGEM — DRGEM CorporationSST-3100 — SHINYOUNG FOR M CO.,LTD.SEDECAL — SEDECALCH-200M — SHIMADZU CORPORATIONNA — GE Hualun Medical Systems Co., LtdDiscovery RF180 — GENERAL MEDICAL MERATE SPACH-200 — SHIMADZU CORPORATIONProvecta HD Single Post Mounting Plate — AIR TECHNIQUES, INC.DRGEM — DRGEM CorporationFH-20HR — SHIMADZU CORPORATIONCH-200M — SHIMADZU CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-16 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | 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 s |
| 2023-04-10 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | 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 b |
| 2018-06-29 | Siemens Medical Solutions USA, Inc | In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break withou |
| 2018-06-29 | Siemens Medical Solutions USA, Inc | In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break withou |
| 2014-10-28 | Summit Industries Inc. | The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury. |
| 2009-01-12 | Del Medical Systems Group | There is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator. |
| 2006-04-28 | Siemens Medical Solutions USA, Inc | Firm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. Risk of injury to o |
| 2005-11-30 | Siemens Medical Solutions USA, Inc | screws on the rollers may become loose |
| 2005-03-10 | Del Medical Systems Group | The Phantom Portable X-Ray System Stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. It the weld fails, the tubehead a |
| 2004-09-30 | Fischer Imaging Corporation | Some VersaRad Systems have a faulty weld that may result in oil leakage. |
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