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

FDA device recall Z-0833-2015 · posted 2014-12-19 · Terminated

Recall details

Recalling firm

Ge Healthcare It

Reason for recall

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.

Action taken

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 permanent product correction will be provided to all customers under FMI85209R. Customers with questions were instructed to contact their local Sales/Service Representative. Also the Remote Online Center (ROC) Customer Care can be reached at 1-800-437-1171.

Root cause

Software design

Status

Terminated

Product code

LMB

Quantity affected

115 units

Distribution

Nationwide Distribution including AZ, OH, WA.

Date initiated

2013-04-19

Date posted

2014-12-19

Date terminated

2016-06-10

Location

Barrington, IL