The Recall Desk
HighFDA (Devices)·Z-1233-2022·Announced 2022-06-15

Medical imaging software measurement accuracy error in Centricity PACS RA1000

GE Healthcare's Centricity PACS RA1000 medical imaging software may display inaccurate distance and area measurements on magnified or scaled images, potentially affecting diagnostic accuracy.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical imaging device with potential for patient harm. The software measurement defect could affect diagnostic accuracy. No harmful outcomes are documented in the source, making this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

GE Healthcare has recalled Centricity PACS RA1000, a picture archiving and communication system (PACS) software used in medical imaging. The software may display inaccurate measurement values when distance and area measurements are performed on magnified images or, specifically in ZFP applications, on lossy images that have been scaled down from their original resolution.

The measurement inaccuracies could affect clinical decision-making if the incorrect values influence diagnosis or treatment planning. The defect affects software versions 3.0 through 3.2 SP8, 4.0 through 4.0 SP14, 6.0 through 6.0 SP10.3, and 7.0 through 7.0 SP0.0.4.7. Approximately 676 units have been distributed worldwide and across all U.S. states.

Users of affected Centricity PACS RA1000 systems should verify measurement values by visual inspection of images and should not rely solely on the software's measurement calculations. Contact GE Healthcare for guidance on software updates or patched versions.

The recalled product

Product
Centricity PACS RA1000
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging Software
Hazard
  • measurement-error
  • software-defect

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 (8)

  • a. Software Version 3.0 through 3.2 SP8
  • No GTIN/DI (Code: 2051372-0XX
  • 2064678-0XX) b. Software Version 4.0 through 4.0 SP14
  • GTIN/DI 00840682124447 (Code: 2062264-0XX)
  • c. 6.0 through 6.0 SP10.3
  • GTIN/DI: 00840682104821 (Code: 2094628-0XX)
  • d. 7.0 through 7.0 SP0.0.4.7
  • GTIN/DI: 00840682145558 (Code: 5824366-0XX)

Distribution

Distributed nationwide across the United States.

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