Device Recall Syngo.plaza

Model Numbers: 10592457, 10863171, 10863173, 10863172; with serial numbers: Serial  100544 100262 100198 100258 200211 100135 100133 100213 100031 100084 100233 100140 200308 100245 100314 100139 100177 100197 100170 100025 100174 100186 100033 100306 100232 100185 100256 100199 100188 100257 100198 100226 100198 100228 100181 100029 100253 100301 100203 100132 100139 100247 100215 100230 100221 100146 100207 100212 100539 100206

Radiology Devices

2

No

Nationwide Distribution

Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. || Syngo.plaza also supports storage and archiving of DICOM Structured reports. || In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. || Syngo.plaza optionally uses a variety of advanced postprocessing applications

Model Number of device  10592457 with serial numbers: Serial 100544 100499 100600 100571 100263 200308 200309 200310 200311 200312 200313 200314 200315 200316 200317 200318 200319 200320 200321 200322 200323 200324 100146 200277 100177 100138 100174 100491 100492 100596 100198 100181 200251 200252 100301 100302 100539

Radiology Devices

2

No

US Nationwide Distribution - in the states of CA, OR, FL, MO, NY, WA, MD, MA, NY, WI, KS, MN and PA.

Syngo.plaza; picture archiving and communications system || Product Usage: || Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.

Device model numbers: 10863171, 10863172, 10863173

Radiology Devices

2

No

Nationwide Distribution including AL CA CT FL IN KS LA MA MD MI MN MO MS NE NY OH OR PA TX WA WI

Syngo Plaza Picture archiving and communication system. || Software only. || PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.

Serial Numbers: 100389, 100198, 100258, 100259, 100538, 100133, 100213, 100214, 100031, 100484, 100362, 100233, 100140, 100141, 100142, 100143, 100144, 100416, 100105, 100106, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100119, 100120, 100457, 100245, 100447, 100364, 100314, 100298, 100299, 100386, 100139, 100027, 100300, 100197, 100025, 100084 100186, 100189, 100190, 100191, 100192, 100195, 100196, 100033, 100306, 100307, 100232, 100256, 100199, 100188, 100194, 100257, 100425, 100029, 100253, 100132, 100247, 100248, 100434, 100491, 100495, 100221, 100212

Radiology Devices

2

No

US Distribution to the states of : AL, CA, CT, FL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX, WI

Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,

Model Number: 10863171, 10863172, 10863173 Serial Numbers:  100262 100198 100258 100259 100135 100538 100133 100031 100105 100106 100109 100110 100111 100112 100113 100114 100115 100116 100117 100119 100120 100416 100461 100245 100447 100364 100298 100299 100386 100139 100027 100440 100441 100559 100025 100033 100196 100189 100190 100191 100192 100195 100186 100232 100450 100449 100256 100199 100188 100194 100198 100029 100253 100203 100204 100132 100139 100434 100476 100495 100491 100206

Radiology Devices

2

No

Distributed throughout the United States.

Syngo.plaza, picture archiving and communications system.