Recall Z-2739-2016 ยท LMB Device, Digital Image Storage, Radiological
Ge Healthcare It
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction other systems have with the Centricity Enterpris
| Date | Sep 6, 2016 (initiated Nov 16, 2012) |
| Status | Terminated |
| Reason | There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned. |
| Root cause | Software design |
| Action | URGENT MEDICAL DEVICE CORRECTION letters dated November 16, 2012 and April 19, 2013, were sent to all affected customers.The letters requested that customers verify that all Enterprise Archive partitions have enough free space available and that the cache disk has at least 10% free space available. The letters further requested that customers whose disks are not being purged to the configured watermarks and the cache disk is almost full to contact their local GE service person. A permanent product correction (Service Pack 12 and release notes) will be provided by GE Healthcare IT. Customers |
| Quantity | 1,379 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.