Reported Jun 30, 2021 · Terminated
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
- Lot codes and dates
CASE and CardioSoft - v6.6xv6.7x and v7.0
- Amount recalled
- 11,295 devices (5,637 US; 5,658 OUS)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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