FDAFDA · Food and drugs·Recall number Z-1773-2019
CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications 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
Published June 19, 2019 · Recall initiated: May 10, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Possible corrosion of the battery contact(s).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardiocommand Inc.
- Distributor
- US Nationwide distribution in the states of CT, VW, OH, IL, DE.
- Lot
- Serial Numbers: 8059, 8060, 8022, 8063, 8211
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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