FDA recall Z-1976-2019

Cardiocommand Inc. · Class III · device

Product

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.

Distribution

United States - AR, NM, PA, TX, and WA.

Key facts

Status
Terminated
Initiation date
2019-06-24
Report date
2019-07-24
Termination date
2021-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tampa, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1976-2019