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Monitor, Patient Position, Light-Beam
FDA product code IWE · Class 1 · Radiology
181
Registered devices
4
Adverse events
8
Recalls
28
510(k) clearances
Devices with this code
MRI-Safe — AADCO MEDICAL, INC.Sun Nuclear MICRO+ MR — SUN NUCLEAR CORP.CARINA — L A P GMBH LASER APPLIKATIONENAADCO — AADCO MEDICAL, INC.Hercules — AADCO MEDICAL, INC.CARINA — L A P GMBH LASER APPLIKATIONENCentralite Patient Positioning Laser — Diacor, Inc.HIT Laser — C-Rad Positioning ABCentralite Patient Positioning Laser — Diacor, Inc.HIT Laser — C-Rad Positioning ABDORADO — L A P GMBH LASER APPLIKATIONENSun Nuclear MICRO+ — SUN NUCLEAR CORP.Hercules — AADCO MEDICAL, INC.APOLLO — L A P GMBH LASER APPLIKATIONENAPOLLO — L A P GMBH LASER APPLIKATIONENAPOLLO — L A P GMBH LASER APPLIKATIONENSun Nuclear MICRO+ MR — SUN NUCLEAR CORP.DORADO — L A P GMBH LASER APPLIKATIONENHercules — AADCO MEDICAL, INC.DORADO — L A P GMBH LASER APPLIKATIONENAADCO — AADCO MEDICAL, INC.AADCO — AADCO MEDICAL, INC.APOLLO — L A P GMBH LASER APPLIKATIONENHercules — AADCO MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-27 | Vision RT Ltd | Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their |
| 2023-09-08 | Omega Medical Imaging, Inc. | An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by th |
| 2023-02-28 | Omega Medical Imaging, Inc. | An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one |
| 2017-03-23 | Omega Medical Imaging, Inc. | Elevating Monitor Suspension column dropping and will not rise back up. |
| 2014-10-24 | GE Healthcare | The alignment lasers are missing the labels required by radiation safety regulations. |
| 2011-09-15 | GE Healthcare, LLC | GE Healthcare has become aware of missing labels on the alignment lasers. |
| 2011-01-26 | GE Healthcare, LLC | GE Healthcare has become aware of a missing laser aperture warning label (i.e. Laser Aperture - Do Not Stare Into Beam) affecting certain Discovery Systems. |
| 2009-09-01 | Hitachi Medical Systems America Inc | The device has a software error that could potentially lead to a misdiagnosis. |
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