| Class 2 Device Recall GE Centricity PACSIW Software |  |
Date Initiated by Firm | February 11, 2010 |
Date Posted | April 16, 2010 |
Recall Status1 |
Terminated 3 on November 15, 2010 |
Recall Number | Z-1402-2010 |
Recall Event ID |
55037 |
510(K)Number | K082318 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
Device that receives, stores and communicates medical images and data from various imaging sources. |
Code Information |
Software version 3.7.3 |
Recalling Firm/ Manufacturer |
Ge Healthcare It 540 W Northwest Hwy Barrington IL 60010-3051
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For Additional Information Contact | GE Customer Care Center 800-437-1171 |
Manufacturer Reason for Recall | There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software when dragging-and-dropping images from the Navigator causing flipping of the images that may impact patient safety. |
FDA Determined Cause 2 | Software design (manufacturing process) |
Action | GE Healthcare issued "Urgent Medical Device Correction" notifications dated February 11, 2010. The initial notification advised users of the patient safety issues associated with the affected product. Separate letters provided the users with specific safety instructions. Accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479.
For additional information, contact the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. |
Quantity in Commerce | 29 units |
Distribution | Worldwide Distribution -- United States (California, Illinois, Indiana, Minnesota, Nevada, New York and Wisconsin), Austria, Canada, Finland, France, Germany, Ireland, Lebanon, Japan, Philippines, Saudi Arabia, Singapore, Switzerland, Turkey, United Arab Emirates and the United Kingdom |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LLZ
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