Centricity CPACS 6.0Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 2 still open.

7 other recalls cover devices cleared under the same FDA submission (K110875); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 31, 2026Open, Classified

   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.

   Z-3168-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. Aug 5, 2024Open, Classified

   GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study.

   Z-3214-2024 · Root cause: Device Design · FDA record ↗

3. May 16, 2019Terminated

   There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.

   Z-1911-2019 · Root cause: Device Design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110875. One submission often covers many models, so check the product and lot details in each record.

• Z-3171-2026 · Jul 31, 2026 · Open, Classified
  Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
• Z-3169-2026 · Jul 31, 2026 · Open, Classified
  Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
• Z-3166-2026 · Jul 31, 2026 · Open, Classified
  Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
• Z-3170-2026 · Jul 31, 2026 · Open, Classified
  Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management
• Z-3167-2026 · Jul 31, 2026 · Open, Classified
  Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
• Z-1466-2022 · Jun 14, 2022 · Terminated
  Centricity PACS Software Version 7.0 SP0.0.4.7
• Z-1233-2022 · Apr 28, 2022 · Open, Classified
  Centricity PACS RA1000