Holder, Radiographic Cassette, Wall-mounted
Radiology · 21 CFR 892.1880
Recent MDR events
32 adverse event reports on file
- SEDECAL X PLUS LP PLUSApr 24, 2026MalfunctionSedecal Usa0001418964-2026-00003
- BUCKY WALL STAND FAMILYMar 17, 2025MalfunctionSiemens Healthcare1000513161-2025-00006
- VS200 WALLSTANDJul 30, 2019MalfunctionDel Medical Inc.1418964-2019-00018
- VS200 WALLSTANDApr 15, 2019MalfunctionDel Medical Inc.1418964-2019-00016
- VS200 WALL STANDApr 12, 2019MalfunctionDel Medical Inc.1418964-2019-00011
- VS200 WALL STANDApr 12, 2019MalfunctionDel Medical Inc.1418964-2019-00012
- VS200 WALL STANDApr 12, 2019MalfunctionDel Medical Inc.1418964-2019-00013
- VS200 WALL STANDApr 12, 2019MalfunctionDel Medical Inc.1418964-2019-00014
- VS200 WALL STANDApr 11, 2019MalfunctionDel Medical Inc.1418964-2019-00010
- VS200 WALL STANDApr 9, 2019MalfunctionDel Medical Inc.1418964-2019-00009
Event type breakdown
Recalls
5 recall events for this product code
- Claymount AssembliTerminatedJun 30, 2014
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate t
Harmony1 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 CFR Subchapter J.
Z-1835-2014 · View FDA record ↗ - Claymount AssembliTerminatedJun 30, 2014
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate t
Claymount 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, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J, and 2) the device's insulation values do not comply with IEC 60601-1 in all cases.
Z-1836-2014 · View FDA record ↗ - Konica Minolta Healthcare, Americas, Inc.TerminatedUnknown
Bucky Stand SU-4000 Input 2017.11.17.
Unintentional U-Arm movement
Z-0659-2019 · View FDA record ↗ - Del Medical, Inc.TerminatedUnknown
VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.
The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.
Z-0761-2016 · View FDA record ↗ - Del Medical, Inc.TerminatedUnknown
VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.
The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.
Z-0762-2016 · View FDA record ↗
Registered firms
33 firms currently registered for this product code
Marketlab Incorporated
Caledonia, MI, US
Wolf X-ray Corp
Battleboro, NC, US
Reina Imaging
CRYSTAL LAKE, IL, US
Drgem Corporation (gimcheon Factory)
Gimcheon-si Gyeongbuk, KR
Livermoretech,inc
Plano, TX, US
Carestream Health, Inc., Global R&d Center
SHANGHAI, CN
Summit Industries, Llc
Niles, IL, US
Pausch Medical Gmbh
ERLANGEN Bavaria, DE
Solutions For Tomorrow Ab
Vackelsang Kronoberg, SE
Compania Mexicana De Radiologia Cgr, S.a. De C.v.
QUERETARO, MX
Rci Operating Co Llc
Hilton, NY, US
Siemens Healthineers Ag
KEMNATH Bavaria, DE
Ge Hangwei Medical Systems Co., Ltd.
Beijing, CN
Aktina Medical Corp.
Congers, NY, US
Agfa N.v.
Mortsel Antwerpen, BE
Philips Electronics Ltd
Mississauga Ontario, CA
Sedecal S.a.
ALGETE Madrid (Province), ES
Dk Medical Systems Co., Ltd.
Pyeongtaek-si Gyeonggi, KR
Shinyoung For M Co., Ltd.
Namyangju-si Gyeonggi, KR
Shimadzu Corporation Medical Systems Division
KYOTO, JP
Arcoma Ab
VAXJO Kronoberg, SE
Ge Healthcare (china) Co., Ltd.
Beijing, CN
Drtech Corporation
Seongnam-si Gyeonggi, KR
Philips Medical Systems Dmc Gmbh
HAMBURG, DE
Del Medical, Inc.
Bloomingdale, IL, US
510(k) clearances
21 clearances for this product code
- Philips Medical Systems (Cleveland), Inc.Aug 11, 1995
K953336 · VRS 3 WALL STAND
- Philips Medical Systems (Cleveland), Inc.Aug 11, 1995
K953402 · UNIVERSIX 190
- CmedApr 28, 1995
K946114 · SENSORI-MOTOR RATING SCALE
- Scott Imaging Intl., Inc.Mar 31, 1995
K946260 · NTBS-1417, 1436, TBS-1417
- American Medical Sales, Inc.Apr 27, 1993
K930230 · RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER
- Tingle X-Ray Products, Inc.Apr 27, 1993
K930249 · BC/WT/PF
- Continental X-Ray Corp.Mar 4, 1993
K925934 · WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT
- Control-X, Inc.Feb 19, 1993
K924445 · BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY