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BR-120

SHIMADZU CORPORATION · Model 566-16510-93 · UDI-DI 04540217047741

IXY
10
510(k) clearances
32
Adverse events
5
Recalls
32
Facilities

Recalls

DateFirmReason
2018-11-08Konica Minolta Healthcare, Americas, Inc.Unintentional U-Arm movement
2015-12-03Del Medical, Inc.The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.
2015-12-03Del Medical, Inc.The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.
2014-03-15Claymount AssembliHarmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21
2014-03-15Claymount AssembliClaymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices are incorrectly labeled in that the label does not list the manufacturer address, th

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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.