Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified syst

FDA device recall Z-2739-2016 · posted 2016-09-06 · Terminated

Recall details

Recalling firm

Ge Healthcare It

Reason for recall

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.

Action taken

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 with questions can contact their GE service representative or the GE Healthcare IT Remote Online Center Customer Care Center at 1-800-437-1171.

Root cause

Software design

Status

Terminated

Product code

LMB

Quantity affected

1,379 units

Distribution

Nationwide Distribution

Date initiated

2012-11-16

Date posted

2016-09-06

Date terminated

2017-01-11

Location

Barrington, IL