FDA Device Recalls

Recalls / —

—#117065

Product

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.

FDA product code
LLZ — System, Image Processing, Radiological
Device class
Class 2
Medical specialty
Radiology
510(k) numbers
K043415
Affected lot / code info
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

Why it was recalled

Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on &amp

Root cause (FDA determination)

Software design

Action the firm took

Consignees were notified of the issue via telephone and site visit by GE Healthcare IT Field Engineers.

Recalling firm

Firm
GE Healthcare
Address
540 W Northwest Hwy, Barrington, Illinois 60010-3051

Distribution

Distribution pattern
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.

Timeline

Recall initiated
2013-02-18
Posted by FDA
2015-02-26
Terminated
2016-05-16
Status
—

Source: openFDA Device Recall endpoint. Recall record ID #117065. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.