Reported Mar 4, 2015 · Terminated

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

GE Healthcare

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 · 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

39 of 39 products

Products covered by this recall
#Product as published
1Catalog Number and Catalog Description: K2000YS , HCA 3.2 UPGRADE KIT (LX)
2K2000YT , HCA 3.2 UPGRADE KIT (S2L)
3K20241SG , C 3.2 TECH S/W CONCURRENT
4K20241SH , C 3.2 DIAG S/W CONCURRENT
5K20241SJ , C 3.2 CLIN S/W CONCURRENT
6K20241SK , C 3.2 TECH S/W SEAT
7K20241SL , C 3.2 DIAGNOSTIC S/W SEAT
8K20241SM , C 3.2 CLINICAL S/W SEAT
9K20241TS , CPACS SOL 2.1 TO LIN 4.0
10K20241TT , CPACS SOL 3.X TO LIN 4.0
11K20241TW , CPACS LIN 3.X TO LIN 4.0
12K20241TY , CPACS LIN 2.X TO LIN 4.0
13K2024SG , C 3.2 TECH S/W CONCURRENT
14K2024SH , C 3.2 DIAG S/W CONCURRENT
15K2024SJ , C 3.2 CLIN S/W CONCURRENT
16K2024SK , C 3.2 TECH S/W SEAT
17K2024SL , C 3.2 DIAGNOSTIC S/W SEAT
18K2024SM , C 3.2 CLINICAL S/W SEAT
19K2024TS , CPACS SOL 2.1 TO LIN 4.0
20K2024TT , CPACS SOL 3.X TO LIN 4.0
Amount recalled
128 systems

Where it was sold

Why it was recalled

Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on &amp

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

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 16, 2016 · Data as of Sep 19, 4:51 PM UTC

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