Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It wi
FDA device recall Z-0034-2014 · posted 2013-10-21 · Terminated
Recall details
- Recalling firm
- GE Healthcare It
- Reason for recall
- 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
- Action taken
- GE Healthcare IT mailed an IMPORTANT PRODUCT INFORMATION letter dated October 2, 2012 to the only consignee of this product. The letter notified the customer of the issue, provided temporary instructions on how to use safely use the software until a new software version can be installed, and advises that a software correction will be made available in the near future. Customers who have any questions can contact their local GEHC-IT service representative or call GE Healthcare's Remote Online Center (ROC) Customer Care Center at 1-800-437-1171.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 1 unit
- Distribution
- USA Nationwide Distribution in the state of OK
- Date initiated
- 2012-10-02
- Date posted
- 2013-10-21
- Date terminated
- 2016-05-16
- Location
- Barrington, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRICITY CARDIO IMAGING (K112570) | Ge Healthcare Integrated IT Solutions | 2011-11-30 |