Z-1773-2019 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 19, 2019
- Initiation Date
- May 10, 2019
- Termination Date
- April 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
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
Reason for Recall
Possible corrosion of the battery contact(s).
Distribution Pattern
US Nationwide distribution in the states of CT, VW, OH, IL, DE.
Code Information
Serial Numbers: 8059, 8060, 8022, 8063, 8211