The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1232-2022·Announced 2022-06-15

Centricity Cardiology CA1000 may display inaccurate distance and area measurements

GE Healthcare is recalling the Centricity Cardiology CA1000 software due to potential inaccurate distance and area measurements on magnified or scaled-down images, which could affect diagnostic accuracy.

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 3/5 (High).

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 a Class II medical device recall involving software that affects diagnostic measurements in cardiology imaging. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High), and the potential for inaccurate diagnostic measurements qualifies as a risk-of-harm scenario.

Plain-English summary

GE Healthcare, LLC is recalling 601 units of the Centricity Cardiology CA1000 software due to a potential for measurement inaccuracy in distance and area calculations. The software may display incorrect distance and area measurements when these calculations are performed on magnified images. Additionally, for ZFP functionality specifically, inaccurate measurements can occur when performed on lossy images that have been scaled down from their original resolution.

The software has been distributed worldwide and throughout all U.S. states, as well as in multiple international locations. Users of this software should refer to the official FDA recall notice for detailed information about remediation options and next steps.

The recalled product

Product
Centricity Cardiology CA1000
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Cardiology Imaging Software
Hazard
Affected units
601

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 (5)

  • a. Software Version 1.0 through 1.0 SP
  • No GTIN/DI (Code: 2022296-0XX)
  • b. Software Version 2.0 through 2.0 SP14H
  • GTIN/DI: 00840682125260 (Codes: 2038437-0XX
  • 2097190-0XX)

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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