Reported Jun 19, 2019 · Terminated
CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage:…
Cardiocommand Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Cardiocommand Inc. · 4920 W Cypress St Ste 110 · Tampa, FL · 33607-3837
Is this the product you have?
- CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A
- REF 0101 - Product UsageIndications
- for Use- Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entrant atrial or atrioventricular paroxysmal tachycardia. - Esophageal electrocardiography for differential diagnosis of complex atrial arrhythmia
- Lot codes and dates
- Serial Numbers
80598060802280638211
- Serial Numbers
- Amount recalled
- 5 units
Where it was sold
Why it was recalled
Possible corrosion of the battery contact(s).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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