Recalls for Device, Digital Image Storage, Radiological

An error message can occur resulting in the prior studies being unavailable for viewing.

The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.

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.

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.

A potential safety issue exists for data transfer between LANTIS OIS system (containing PRIMEVIEW or PRIMEVIEW Data Gateway) and the Sequencer V&R system via a third party interface is used.

There is a potential safety issue in regard to data transfer between LANTIS OIS system and the hospital Information System (HIS) when the HL7 (ADT) interfact is used.

Video device is not able to assign the correct time/date stamp.

Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis.

Product serving as data backup protection does not contain 100% data backup for all NetPractice customers on a daily basis.

Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis.

Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where study split operations are not correctly replicated to a secondary 'shadow' archive.

Patient Identification numbers and names may be applied to images from another patient due to a software issue. This failure mode can only occur when the pre-load function of the SDC ultra is used.

Failure to update correctly when re-transmitting an image from the modality.

Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.

Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.

Imaging archive system software mismatches images and patient names.

The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the progression of disease.

The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of disease.

Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.