Monitor, Patient Position, Light-beam

The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.

Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).

Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085

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 location.

Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

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 the installed safety cable.

Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory

Elevating Monitor Suspension column dropping and will not rise back up.

GE Discovery MR950 MRI system

The alignment lasers are missing the labels required by radiation safety regulations.

GE Healthcare Signa, Discovery and Optima.

GE Healthcare has become aware of missing labels on the alignment lasers.

GE Healthcare DISCOVERY MODEL NM/CT 670

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.

Hitachi Oasis Magnetic Resonance Scanners Software V1.0C

The device has a software error that could potentially lead to a misdiagnosis.