Centricity Cardio Imaging 5.0 is a software only recall: Software Issue
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only…
Why was Centricity Cardio Imaging 5.0 is a software only recalled?
GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting "Compare Study" from the Study List, or by opening prior studies in the Patient Folder. In these cases, the Viewer differentiates the studies wityh a label (Curr
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?
Software Version: 5.0
- Product
- Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only…
- Recalling firm
- GE Healthcare It
- Quantity
- 1 unit
- Distribution
- USA Nationwide Distribution in the state of OK
- Recall date
- October 30, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)