The Recall Desk
HighFDA (Devices)·Z-1927-2021·Announced 2021-06-30

Cardiac assessment system may display test reports in wrong patient records

GE Healthcare's Case Cardiac Assessment System and CardioSoft diagnostic application may display one patient's cardiac test report in another patient's medical record under certain conditions. No patient injuries have been reported.

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 a Class II recall with no reported illnesses or injuries. However, it involves a medical device with potential for patient harm—a data integrity issue that could result in healthcare providers accessing another patient's cardiac test data during clinical decision-making. This qualifies as a 'risk-of-harm product where injury has not yet been reported,' per FDA severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling the Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application (software versions 6.6x, 6.7x, and 7.0). The systems are used to perform and interpret cardiac stress tests and electrocardiogram (ECG) exercises.

The recall addresses a data integrity issue: under a certain sequence of events, a patient's cardiac test report in PDF format may be displayed in another patient's record when viewed through an Electronic Medical Record (EMR) system or similar platform. This could potentially result in a healthcare provider accessing incorrect patient data while making clinical decisions.

Approximately 11,295 devices have been distributed worldwide, including 5,637 units in the United States. The product has been distributed to hospitals, clinics, and government/military facilities across the U.S. and to numerous countries globally.

GE Healthcare recommends that users review their system configuration and implement any available software updates. Affected facilities should contact GE Healthcare for guidance on mitigating measures or a software fix.

The recalled product

Product
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Cardiac Assessment / Diagnostic
Hazard
  • patient-data-mismatch
  • data-integrity
  • medical-record-error

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 (2)

  • CASE and CardioSoft - v6.6x
  • v6.7x and v7.0

Distribution

Distributed nationwide across the United States.

Related recalls

Same category