Reported Nov 6, 2013 · Terminated

The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by…

GE Healthcare It

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare It · 540 W Northwest Hwy · Barrington, IL · 60010-3051

Is this the product you have?

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 the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.

Lot codes and dates: GE Centricity PACS Versions
3.1.1.2
3.2
3.2.0.1
3.2.0.2
3.2.1
3.2.2
3.2.2.1
3.2.2.2
3.2.2.3
3.2.6
4.0
4.0.1
Amount recalled: 623 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives…

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Other recalls from GE Healthcare It

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