Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning GE Healthcare Centricity Universal Viewer Zero Footprint Client (ZFP), Centricity PACS RA1000 Workstation (RA1000), Centricity Radiology RA600 (RA600), Centricity Cardiology CA1000 (CA1000) and Centricity Enterprise Web (CWeb) [HKMD No.: 210471].
According to the MHRA, the manufacturer has become aware of two potential issues where inaccurate Distance and Area measurements can be displayed.
Both issues impact the following modality generated image series: Computed Radiography (CR), Digital X-Ray Radiography (DX), X-Ray Angiography (XA), X-Ray Radio Fluoroscopy (XRF), Radio Fluoroscopy (RF), and Mammography (MG) including saved DICOM Grayscale Presentation State (GSPS).
Issue 1
Distance and Area measurements can display inaccurate measurement values when performed on magnified images.
True size printing on film/paper for images will also reflect these inaccurate measurement values.
Images exported from RA600 or CA1000 to a storage medium (e.g., CD) will also reflect these inaccurate measurement values.
The measurement value is always overestimated (measured size is larger than true size).
Issue 2
Specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
The measurement value is always underestimated (measured size is smaller than true size).
For further information, please visit https://mhra-gov.filecamp.com/s/snGTGi2uTbWauxtU/d
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 06 Dec 2022