FDAClass IIMarch 4, 2015

The Centricity PACS Workstation is intended for use as recall

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

Why was The Centricity PACS Workstation is intended for use as 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare…
Recalling firm
GE Healthcare
Quantity
128 systems
Distribution
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.
Recall date
March 4, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls