Device, Digital Image Storage, Radiological

iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.

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

iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.

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

Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and m

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.

Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communi

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.

LANTIS Oncology Information System (OIS)

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.

LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essen

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.

An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to capture still images and to record video during the sur

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

Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad)

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

Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice).

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

Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power).

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