The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1214-2015·Announced 2015-03-04

GE Healthcare Recalls Centricity PACS Workstation Due to Exam Merge Failure

GE Healthcare is recalling 128 Centricity PACS Workstation systems because a software defect may cause exam records to go missing in single Study Mode.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a software defect resulting in missing records rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

GE Healthcare is recalling 128 Centricity PACS Workstation systems. The 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 used as a clinical review workstation throughout healthcare facilities.

The recall is due to a software defect where using the Merge Exam feature in single Study Mode may result in a Missing Study Record. This failure can prevent users from displaying or sending exams. The affected systems were distributed nationwide in the United States, including specific states such as 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, as well as in Bermuda.

Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue. The recall involves specific software upgrade kits and concurrent software licenses, including catalog numbers such as K2000YS, K2000YT, and various K2024 and K2035 series codes.

The recalled product

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…
Manufacturer
GE Healthcare
Category
Medical Device — PACS Workstation
Hazard
Affected units
128

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

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