CH-200

SHIMADZU CORPORATION · Model 503-58100-27 · UDI-DI 04540217014491

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

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 shaft.
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 behind the bracket, i
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 without triggering the saf
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 without triggering the saf
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 operators fingers.
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 arm assembly could fa
2004-09-30	Fischer Imaging Corporation	Some VersaRad Systems have a faulty weld that may result in oil leakage.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.