Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0116-2014 — The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout t

U.S. FDA — Device Enforcement · United States · 2013-06-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0116-2014
Date of alert: 2013-06-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare It
Product category: device
Product type: Devices

Reported risk: GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS-Driven integration, the "close" button closes the exam in RIS-IC, but does not close the exam in Centricity PACS RA1000 Workstation. 2) Interrupted workflow could break the

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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