FDA-Device2026-09-23Class IIPROCESSING DEFECT

GE Healthcare Centricity PACS Server V7 recalled for patient data mislabeling risk

OTHERNationwide distributionMedical devices

What this means

GE Healthcare's Centricity PACS Server V7, used by hospitals and imaging centers to store and display patient X-rays and scans, has a problem: when old images are transferred from an older system, they can occasionally be linked to the wrong patient record. If a doctor pulls up what they think is John Smith's scan, they might see Jane Doe's instead.

  • If your facility uses Centricity PACS Server V7, contact GE Healthcare for guidance on checking your system.
  • Review any recent patient image transfers from legacy systems to ensure images are correctly associated with the right patients.
  • Follow GE Healthcare's instructions for verifying data integrity after any system migrations.
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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
116 systems
Manufactured in
500 W Monroe St, N/A, Chicago, IL, United States
Products
Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3169-2026

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