The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic…

Date

March 4, 2015

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare

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.

Reason

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

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.

Quantity

128 systems

Codes and lots

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

Recall started

Feb. 18, 2013

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

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

Recall number

Z-1214-2015

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1214-2015. The agency record governs; check it and the company before acting.