Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity PACS RA1000 Workstation

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall GE Centricity PACS RA1000 Workstation see related information
Date Initiated by Firm December 12, 2008
Date Posted January 23, 2009
Recall Status1 Terminated 3 on May 18, 2010
Recall Number Z-0836-2009
Recall Event ID 50538
510(K)Number K043415  
Product Classification Picture archiving and communications system - Product Code LLZ
Product GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. 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.
Code Information Software versions PACS 1.0CSR5/2.0CSR1 and all service packs
Recalling Firm/
Manufacturer		 GE Healthcare Integrated IT Solutions
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact GE Customer Care Center
800-437-1171
Manufacturer Reason
for Recall		 There is a potential patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it.
FDA Determined
Cause 2		 Software design
Action GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 12/12/08 of the software anomaly resulting in a patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 414-918-4653.
Quantity in Commerce 138 units
Distribution Worldwide Distribution including USA and countries of Canada, China, Denmark, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Lebanon, Mexico, Netherlands, Saudi Arabia, Spain, Taiwan and United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
-
-