Recall Z-1976-2019— Cardiocommand Inc.

Name: FDA recall Z-1976-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-24

Class III · Terminated

Class III FDA medical device recall by Cardiocommand Inc., initiated 2019-06-24, terminated 2021-04-01. FDA's recall record names no specific 510(k) clearance for this event. Product: TAPSYSTEM Model 2A, REF 8002A. Reason: There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly..

Recalling firm: Cardiocommand Inc.
Classification: Class III
Status: Terminated
Initiated: 2019-06-24
Terminated: 2021-04-01
Firm location: Tampa, FL, United States

Product description

TAPSYSTEM Model 2A, REF 8002A

Reason for recall

There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.

Data sourced from openFDA. This site is unofficial and independent of the FDA.