Recalls for System, X-ray, Film Marking, Radiographic

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.

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.

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.

Digital Skin Mammography Marker separating from the backing of the spot material

Digital Skin Mammography Marker separating from the backing of the spot material

Digital Skin Mammography Marker separating from the backing of the spot material

Digital Skin Mammography Marker separating from the backing of the spot material

A localized fog pattern appears on the film.

A localized fog pattern appears on the film.

A localized fog pattern appears on the film.

Mislabeling; Product labeled Cronex 10T actually contains Afga, Curix Ultra UVL Plus.

Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels

There is a potential for imaging artifact to mimic calcifications on patient's mammograms

There is a potential for imaging artifact to mimic calcifications on patient's mammograms

There is a potential for imaging artifact to mimic calcifications on patient's mammograms