Recall Z-0833-2015 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. 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 that other systems have with the Centricity Enterprise archive. The intended users for Centricity Enterprise Archive are
| Date | Dec 19, 2014 (initiated Apr 19, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full. |
| Root cause | Software design |
| Action | General Electric sent an Urgent Medical Device Correction letter dated April 19, 2013, to all affected customers. The letter instructs customers to ensure that Enterprise Archive partitions have enough free space available, in particular the cache disk should have at least 10% free space available. This could be facilitated by setting appropriate disk limits and watermarks on the individual libraries in Enterprise Archive. In case the disks are not being purged to the configured watermarks and the cache disk is almost full, customers are requested to contact their local GE service person. A pe |
| Quantity | 115 units |
| Distribution | Nationwide Distribution including AZ, OH, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.