Centricity CPACS 7.0 (UDI 00840682145558)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682145558), received between Nov 26, 2024 and Nov 26, 2024 — classified as 1 injury.

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

9 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 15, 2022Open, Classified

   Inaccurate Distance and Area measurements with use of Global Stack viewport.

   Z-1566-2022 · Root cause: Process design · FDA record ↗

2. Apr 28, 2022Open, Classified

   Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

   Z-1233-2022 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ED PHYSICIAN REVIEWED CHEST X-RAY ON CENTRICITY PACS - RA1000 CLINICAL WORKSTATION WITH INCLUDE COMPARISON ENABLED. PHYSICIAN DID NOT RECOGNIZE CHEST X-RAY IMAGE WAS A COMPARISON AND TREATED PATIENT FOR A PNEUMOTHORAX FROM AN OLD COMPARISON CHEST X-RAY BY PLACING A CHEST TUBE INTO LUNG. PATIENT'S CURRENT CHEST X-RAY WAS NORMAL (NO PNEUMOTHORAX). PACS ADMIN REPORTS NO OTHER PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 20789000 ↗

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-3168-2026 · Jul 31, 2026 · Open, Classified
  Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing
• Z-3169-2026 · Jul 31, 2026 · Open, Classified
  Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
• Z-3167-2026 · Jul 31, 2026 · Open, Classified
  Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical 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-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-3214-2024 · Aug 5, 2024 · Open, Classified
  GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
• Z-1466-2022 · Jun 14, 2022 · Terminated
  Centricity PACS Software Version 7.0 SP0.0.4.7
• Z-1911-2019 · May 16, 2019 · Terminated
  Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and pro