IWYClass I

Holder, Head, Radiographic

Radiology · 21 CFR 892.1920

MDR events17All time

Recalls1All time

Registered firms29Currently listed

510(k) clearances10All time

Recent MDR events

17 adverse event reports on file

HEAD ADAPTER BRACKETApr 12, 2023
MalfunctionHill-rom Company, Inc.16723468
ADAPTER X-RAY 3-JOINT WIDEApr 4, 2022
MalfunctionTrumpf Medizin Systeme Gmbh + Co. Kg3007143268-2022-00008
TYPE-S HEAD, NECK & SHOULDER THERMOPLASTICOct 5, 2017
MalfunctionMedtec, Inc. (civco)6915905
TOSHIBA CT SYSTEM ACCESSORIES, CARBON FIBERMay 9, 2013
MalfunctionCfi Medical Solutions3110505
TYPE-S EXTENSIONMar 6, 2009
OtherMedtec, Inc (dba. Civco Medical Solutions)1932738-2009-00001
TYPE-S OVERLAYNov 12, 2008
OtherMedtec, Inc. (dba. Civco Medical Solutions)1932738-2008-00002
TYPE-S PT POSITIONING SYSTEMOct 20, 2008
InjuryCivco1204464
TYPE-S HEAD EXTENSIONApr 20, 2007
MalfunctionCivco Medical Solutions, Med-tec Inc.1932738-2007-00001
TYPE-S SYSTEMJun 16, 2006
OtherCivco1932738-2006-00004
MEDTEC DISPOSABLE TYPE-S THERMOPLASTIC MASKJul 1, 2005
OtherMedtec1932738-2005-00010

Event type breakdown

Other7

Malfunction6

Death2

Injury2

Most-reported manufacturers

Civco2 Med-tec,inc.2 Medtec2 Unspecified1 Cfi Medical Solutions1 Civco Medical Solutions, Med-tec Inc.1 Hill-rom Company, Inc.1 Medtec, Inc (dba. Civco Medical Solutions)1

Recalls

1 recall events for this product code

Brainlab AG
TerminatedJul 3, 2007
BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment
Target Alignment Error : A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings and BrainLAB planning software resulted in a 1.25 mm shift in target area alignment during radiosurgery treatment.
Z-1010-2007 · View FDA record ↗

Registered firms

29 firms currently registered for this product code

510(k) clearances

10 clearances for this product code