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FDAApril 19, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

ge healthcare

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application — Recall Details · AllClear