GE Healthcare Centricity Universal Viewer Breast recall
GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various…
Why was GE Healthcare Centricity Universal Viewer Breast recalled?
When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagnosis.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Centricity Universal Viewer versions 6.0 SP4 or higher with Breast Imaging integrated with either IDI Mammo Workstation version 4.7.x or any version of SenoIris.
- Product
- GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 297 (131 US; 166 OUS)
- Distribution
- Worldwide Distribution: US (nationwide) in states of: AZ, CA, CO, DE, FL, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, MT, NE, NJ, NV, NY, OH, PA, PR, SC, SD, TN, TX, VA, VT, and WI; and countries of: Antigua, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Cote d'Ivoire, France, Germany, Guatemala, India, Italy, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Panama, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
- Recall date
- February 13, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)