GE Healthcare recalls Centricity PACS-IW with Universal Viewer version 5.0 due to potential missing images in exams without warning. Affected units may display incomplete medical images during radiology procedures.
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
GE Healthcare is recalling Centricity PACS-IW with Universal Viewer version 5.0 because it may show missing medical images during exams without warning. This could lead to incorrect diagnoses if healthcare providers rely on incomplete images for patient care.
The system may display medical images without warning if one or more images or image series are missing from exams. This could lead to incomplete diagnostic interpretations, especially for critical procedures like mammography where accurate image review is essential.
Healthcare professionals using Centricity Universal Viewer version 5.0 for medical imaging, particularly those handling mammography images. Those using the system without proper regulatory compliance may face risks of incomplete image interpretation.
Check for the model number 2068177-001 on the Centricity Universal Viewer version 5.0. The product was sold with the name 'Centricity Universal' and may have specific site IDs or product IDs listed in the recall notice.
Review the product ID numbers listed in the recall notice to confirm if your unit is affected.
The recall is due to a potential issue where one or more images or image series may be missing from exams without a warning displayed in the viewer.
The recall notice does not specify a remedy, so no action is required unless you see missing images during use.
The product is safe for general use, but healthcare professionals should verify image completeness before making diagnostic decisions.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1885-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1885-2019 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.