System, X-ray, Film Marking, Radiographic
Radiology · 21 CFR 892.1640
Recent MDR events
24 adverse event reports on file
- A-SPOTJun 23, 2026InjuryBeekley Corporation9021987-2026-00003
- TOMOSPOTApr 2, 2026InjuryBeekley Corporation9021987-2026-00001
- CT-SPOTSep 2, 2025InjuryBeekley Corporation9021987-2025-00001
- TOMOSPOT AND V-SPOTDec 18, 2024InjuryBeekley Corporation9021987-2024-00004
- O-SPOTMay 20, 2024InjuryBeekley Corporation9021987-2024-00002
- TOMOSPOTNov 15, 2019InjuryBeekley Corporation9021987-2019-00004
- CT-SPOTSep 9, 2019InjuryBeekley Corporation9021987-2019-00003
- CT-SPOTJul 19, 2019InjuryBeekley Corporation9021987-2019-00002
- TOMOSPOTMay 6, 2019InjuryBeekley Corporation9021987-2019-00001
- A-SPOTOct 22, 2018InjuryBeekley Corporation9021987-2018-00005
Event type breakdown
Most-reported manufacturers
Recalls
15 recall events for this product code
- GE Healthcare, LLCTerminatedFeb 27, 2013
GE Healthcare Definium 5000 / 5220493 X-Ray System
When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.
Z-0703-2013 · View FDA record ↗ - GE Healthcare, LLCTerminatedFeb 27, 2013
GE Healthcare Definium 5000/5220493-2 X-Ray System
When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.
Z-0704-2013 · View FDA record ↗ - GE Healthcare, LLCTerminatedFeb 26, 2013
GE Healthcare Brivo XR385 DR-F/ X-Ray System
GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
Z-0761-2013 · View FDA record ↗ - Beekley CorporationTerminatedJul 31, 2012
Beekley S-Spots Floral Skin Markers -Order Number: 750
Digital Skin Mammography Marker separating from the backing of the spot material
Z-2109-2012 · View FDA record ↗ - Beekley CorporationTerminatedJul 31, 2012
Beekley A-Spots Floral Skin Markers -Order Number: 751
Digital Skin Mammography Marker separating from the backing of the spot material
Z-2110-2012 · View FDA record ↗ - Beekley CorporationTerminatedJul 31, 2012
Beekley O-Spots Floral Skin Markers -Order Number: 752
Digital Skin Mammography Marker separating from the backing of the spot material
Z-2111-2012 · View FDA record ↗ - Beekley CorporationTerminatedJul 31, 2012
Beekley Altus Floral Skin Markers -Order Number: 754
Digital Skin Mammography Marker separating from the backing of the spot material
Z-2112-2012 · View FDA record ↗ - AGFA Corp.TerminatedApr 11, 2006
Cronex 10T, 14x17, Medical Screen Film, X-ray Film, 100 Sheet Box
A localized fog pattern appears on the film.
Z-0754-06 · View FDA record ↗ - AGFA Corp.TerminatedApr 11, 2006
Curix Ultra UV-L Plus, Medical Screen Film, X-ray Film, 14x17, 100 Sheet Box
A localized fog pattern appears on the film.
Z-0755-06 · View FDA record ↗ - AGFA Corp.TerminatedApr 11, 2006
Radiomat SG, 11x14, Medical Screen Film, X-ray Film, 100 Sheet Box and 14x17, 100 Sheet Box
A localized fog pattern appears on the film.
Z-0756-06 · View FDA record ↗
Registered firms
37 firms currently registered for this product code
Wolf X-ray Corp
Battleboro, NC, US
Nucletron B.v.
VEENENDAAL Utrecht, NL
Orthofix Srl
BUSSOLENGO Verona, IT
Umi Intl.
Norwood, NJ, US
Brady Worldwide
Milwaukee, WI, US
Monteris Medical Corp
Minnetonka, MN, US
All-craft Wellman Products, Inc.
Willoughby, OH, US
Brady Mexico, S. De R.l. De C.v.
Tijuana Baja California, MX
Greens Surgicals Private Limited
Vadodara Gujarat, IN
Brainlab Se
Munich Bavaria, DE
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Hologic Surgical Products Costa Rica, S.r.l.
El Coyol Alajuela, CR
Lj Business Corporation
Chuo Tokyo, JP
Ecotron Co., Ltd.
Seoul, KR
Solstice Corporation
South Portland, ME, US
Hologic, Inc.
Marlborough, MA, US
Mainline Medical Dental Supply
North York Ontario, CA
Sterigenics U.s., Llc
Corona, CA, US
Beekley Corporation
Bristol, CT, US
Isomedix Operations Inc.
WHIPPANY, NJ, US
Maire-didier
Chaumont Haute-Marne, FR
Radiation Products Design, Inc.
ALBERTVILLE, MN, US
Sts Corporation
Duluth, GA, US
Zirkonzahn Srl
Gais Bolzano, IT
Depuy Orthopaedics, Inc.
WARSAW, IN, US
510(k) clearances
18 clearances for this product code
- Miles Inc., Agfa DivisionSep 30, 1994
K942883 · DIGITAL I.D. CAMERA
- I.Z.I. Corp.Nov 19, 1993
K930752 · CT/MRI TOPOGRAPHIC MARKER
- Fujifilm Medical System U.S.A., Inc.Jul 26, 1993
K932357 · FUJI EC ID CAMERA
- Solstice Corp.May 18, 1993
K925892 · SOLSTICE XRAY RING MARKER PAD
- Planmeca USA, Inc.Mar 4, 1993
K923533 · ADMARK
- Eastman Kodak CompanyMar 4, 1993
K926404 · KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L
- Fischer Imaging Corp.Nov 27, 1992
K924345 · RADIOGRAPHIC FILM MARKETING SYSTEM
- Bennett X-Ray TechnologiesNov 27, 1992
K925332 · BENNETT X-RAY ID PLUS