medical Class II Updated 2021-06-30

GE Healthcare, LLC recalls Case Cardiac Assessment System for Exercise Testing and Card

Recalled Product

Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application


Hazard / Issue

If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an Electronic Medical Record (EMR) or a similar system.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: CASE and CardioSoft - v6.6x, v6.7x and v7.0
View official government recall

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