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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 037 01 11 000
Date submitted: 1/18/2011
Manufacturer:GE Healthcare.
Device Type:GE Centricity PACS Web Diagnostic.
Description:Picture archiving and communication system, radiology.
Medical Device Identifier:Software version: 1.0.0.x
Reason of Field Safety Corrective Action:Safety Issue #1 The “View Position” and laterality (e.g. LCC, RCC, LMLO, RMLO) is not displayed on mammography images on the Web DX viewer. Mammography images are expected to display view position and image laterality to support interpretation and diagnosis. The standard clinical practice is to verify laterality prior to mammographic‐based interventions or decisions. If the clinician does not verify correct laterality by an alternate means (e.g. by reviewing a correct hard copy, or by viewing the image on a mammography diagnostic workstation where the ‘View Position’ and laterality are correctly displayed), then they could plan or perform an intervention or make diagnostic or treatment planning decisions on the wrong anatomic side or site. Safety Issue #2 Image orientation or annotations are not displayed properly for an image on WebDX viewer when displaying a ‘Key Image Note’ that refers to multiple images with multiple presentation states. If a referring clinician relied exclusively on the ‘Key Image Note’ for intervention or treatment decisions, and the annotations were essential for identifying or recognising the key finding, this could contribute to an incorrect or sub‐optimal intervention or treatment planning decision. Details: The ‘Key Image Note’ feature allows a Radiologist to cue a referring clinician to critical findings/information based on selected key images. The ‘Key Image Note’ can refer to multiple presentation states when it references more than one image in cases. Examples of different presentation states that might be included in a ‘Key Image Note’ include, but are not limited to: 1) Images are not oriented in the same manner; 2) Images do not have matching modality LUT information’ 3) Images do not have matching shutter information or graphic layer information. Under these conditions, when a user opens the ‘Key Image Note’ on a WebDX viewer, the presentation state is not fully preserved. Consequently, some image annotations are not displayed. Safety Issue #3 When a user is viewing a ’Current’ exam and opens a ‘Prior’ exam concurrently, the presentation display settings are not applied to the ‘Prior’ exam. Examples of presentation display settings include, but are not limited to, orientation markers, annotations and window levelling. This may result in image orientation, window level, invert, and annotations not being displayed as intended when an exam is displayed as a ‘Prior’. This happens regardless of whether the exam is displayed as a ‘Prior’ manually or via a hanging protocol. If a historical exam is opened independently (i.e. not while a ‘Current’ exam is open), all presentation state and related annotation information is retained and correctly applied to the historic exam.
Remedy Action:Safety Instructions #1: Clinicians should use alternative means of verifying side/site prior to mammographic‐based interventions or decisions. Safety Instructions #2: To ensure display of all annotations, the Radiologist should create an individual ‘Key Image Note’ (KIN) for each image. Key findings should also be communicated in the final report. Finally, the referring clinician should not rely exclusively on the ‘Key Image Note’ for intervention planning. Safety Instructions #3: In order to ensure that all presentation state information is applied to a displayed exam, a historical exam should be opened independently to view presentation state and related annotation information.
Athorized Representative/Importer/Distributor:GE Healthcare, Riyadh, (01) 4600530
Report Source:http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
Source Ref. Number:FR-2011-01-17-004
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments