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

FDA device recall Z-0116-2014 · posted 2013-10-30 · Terminated

Recall details

Recalling firm

GE Healthcare It

Reason for recall

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

Action taken

URGENT MEDICAL DEVICE CORRECTION letters dated June 11, 2013 was mailed to all customers alerting them to these potential safety issues. The software was modified to correct these defects and a GE Healthcare service representative will contact each customer to make arrangements for installation of the new software version at no charge to the customer. Customers with concerns or questions about the market action can contact their local GE Healtchcare IT service representative or GE Healthcare's Remote Online Center - Customer Care Center at 1-800-437-1171.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

623 units

Distribution

Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA,

Date initiated

2013-06-11

Date posted

2013-10-30

Date terminated

2016-06-10

Location

Barrington, IL

Related 510(k) clearances