FDA-Device2026-09-23Class IIPROCESSING DEFECT

GE Healthcare Centricity PACS software recalled for patient data mix-up risk

OTHERNationwide distributionMedical devices

What this means

GE Healthcare's Centricity PACS imaging software can sometimes link historical medical images to the wrong patient when data is moved from older systems. If this happens, a doctor might see one patient's scans under another patient's record, potentially leading to wrong diagnoses or delayed care.

  • Contact GE Healthcare or your IT department to check if your facility's system is affected.
  • Follow any guidance from GE Healthcare regarding data verification or software updates.
  • Review procedures to ensure patient images are correctly matched to patient records.
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The agency's original wording
Hazard

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution.
Affected count
1443 systems
Manufactured in
500 W Monroe St, N/A, Chicago, IL, United States
Products
Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3168-2026

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