Device Recall GE Centricity PACS

GE Centricity PACS RA1000 Workstation Software versions 2.1.X.X. and 3.0.X.X. used in combination with the GE Senographe 2000D, Senographe DS or Senographe Essential.

Radiology Devices

2

No

Worldwide including USA, Australia, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey and the United Kingdom.

GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010

Software Versions: 3.7.1, 3.7.1.1, 3.7.2, 3.7.3.1, 3.7.3.3, 3.7.3.4, 3.7.3.5, 3.7.6.3, 3.7.3.7, and 3.7.3.8

Radiology Devices

2

No

Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Internationally to Austria, Azerbaijan, Bahrain, Belgium, Bosnia, Brazil, Canada, Columbia, Egypt, France, Germany, Ghana, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Libya, Lithuania, Mexico, Netherlands, Nigeria, Palestine, Poland, Qatar, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Yemen. Center Recommended Depth - Consumers/User**

Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.

Catalog Number and Catalog Description:  K2000YS , HCA 3.2 UPGRADE KIT (LX) ; K2000YT , HCA 3.2 UPGRADE KIT (S2L) ; K20241SG , C 3.2 TECH S/W CONCURRENT ; K20241SH , C 3.2 DIAG S/W CONCURRENT ; K20241SJ , C 3.2 CLIN S/W CONCURRENT ; K20241SK , C 3.2 TECH S/W SEAT ; K20241SL , C 3.2 DIAGNOSTIC S/W SEAT ; K20241SM , C 3.2 CLINICAL S/W SEAT ; K20241TS , CPACS SOL 2.1 TO LIN 4.0 ; K20241TT , CPACS SOL 3.X TO LIN 4.0 ; K20241TW , CPACS LIN 3.X TO LIN 4.0 ; K20241TY , CPACS LIN 2.X TO LIN 4.0 ; K2024SG , C 3.2 TECH S/W CONCURRENT ; K2024SH , C 3.2 DIAG S/W CONCURRENT ; K2024SJ , C 3.2 CLIN S/W CONCURRENT ; K2024SK , C 3.2 TECH S/W SEAT ; K2024SL , C 3.2 DIAGNOSTIC S/W SEAT ; K2024SM , C 3.2 CLINICAL S/W SEAT ; K2024TS , CPACS SOL 2.1 TO LIN 4.0 ; K2024TT , CPACS SOL 3.X TO LIN 4.0 ; K2024TW , CPACS LIN 3.X TO LIN 4.0 ; K2024TY , CPACS LIN 2.X TO LIN 4.0 ; K2024WH , CPACS S2.1 TO L4.0 SWOP ; K2024WJ , CPACS S3.X TO L4.0 SWOP ; K2024WK , CPACS L3.X TO L4.0 SWOP ; K2024WL , CPACS L2.X TO L4.0 SWOP ; K20351SM , CPACS SOL 2.1 TO LIN 3.2 ; K20351SN , CPACS SOL 3.X TO LIN 3.2 ; K20351SP , CPACS LIN 2.X TO LIN 3.2 ; K20351SR , CPACS LIN 3.X TO LIN 3.2 ; K20351ZA , CPACS 3.2.X TO 3.2SP7 UPG ; K2035SM , CPACS SOL 2.1 TO LIN 3.2 ; K2035SN , CPACS SOL 3.X TO LIN 3.2 ; K2035SP , CPACS LIN 2.X TO LIN 3.2 ; K2035SR , CPACS LIN 3.X TO LIN 3.2 ; K2035SW , CPACS 3.2 BASE LIC 20K ; K2035ZA , CPACS 3.2.X TO 3.2SP7 UPG ; P2035SW , CPACS 3.2 BASE LIC 20K ; 2079312-001 , ND SW CPACS 3.2 SP8 WS APP WEB DWNLD

Radiology Devices

2

No

Distributed US (nationwide) including the states of AK, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WV, and the country of Bermuda.

The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.

Centricity PACS versions 3.1.1.x through 3.2.1.x

Radiology Devices

2

No

Worldwide distribution including US nationwide, Puerto Rico, Australia, Austria, Belgium, Bermuda, CANADA, Denmark, Egypt, ENGLAND, France, Germany, India, Ireland, Hong Kong, Korea, Kuwait, Italy, Malta, Netherlands, Portugal, Qatar, Saudi Arabia, SCOTLAND, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.

GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System || Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.

GE Centricity PACS RA1000 Workstation Software versions 2.1.X. and 3.0.X.

Radiology Devices

2

No

Worldwide Distribution - USA, Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Kuwait, Malaysia, New Zealand, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.

GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010