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arcc

APOLLO ENTERPRISE IMAGING CORP · Model 01 · UDI-DI 00860002800301

LMD

510(k) clearances

173

Adverse events (1 deaths)

Recalls

149

Facilities

Description

Apollo arcc® is a Health Information System facilitating the combination of patient information received from another information system (HL7 interface) with clinical multimedia (images, video, audio and other formats) and clinical information in a highly organized and secure environment. Patient information may also be entered directly into arcc. The workflow is representative of standard clinical specialties including but not limited to pathology, gastroenterology, dermatology, surgery, etc. Digital media can be imported via TCP/IP or via digital capture through direct connection to a modality device (Ex. would be a microscope mounted camera).

Recalls

Date	Firm	Reason
2020-09-11	Skytron, Div. The KMW Group, Inc	VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display
2020-03-10	Skytron, Div. The KMW Group, Inc	Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display a Blank image wh
2015-12-04	CompView Medical, LLC	The attachment of the NuCART Spring Arm to the NuCART horizontal boom may come apart if the securing ring (snap ring) was not installed correctly causing the spring arm to release
2015-05-06	Siemens Medical Solutions USA, Inc	A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching
2014-06-25	Karl Storz Endoscopy	KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessat
2012-04-19	Ge Healthcare It	GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to
2009-12-11	Stryker Endoscopy	Device will not able to assign the correct time/date stamp for saved filed after December 31, 2009. On Jan 1, 2010, the device system date for all SDC Pro 2 units will re-start fr
2008-12-12	GE Healthcare Integrated IT Solutions	Software error: There are two potential safety situations with Centricity Enterprise Web software - a forced log off may occur while using the Centricity Enterprise Web during an o
2007-12-11	AGFA Corp.	Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by
2007-05-02	Siemens Medical Solutions USA, Inc	System could crash and result in data loss.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.