FDA Device recall Z-1976-2019
TAPSYSTEM Model 2A, REF 8002A
- FDA Device
- Class III
- terminated
- Published 2019-07-24
On 2019-07-24 the FDA classified a Class III recall of TAPSYSTEM Model 2A, REF 8002A by Cardiocommand, citing there is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1976-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-06-24 |
| Published | 2019-07-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cardiocommand |
| Distribution | AR, NM, PA, TX, WA |
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.
Identifiers
| code_info | SERIAL NUMBERS: 2197A, 2196A, 2198A, 2199A, 2200A, and 2201A, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1976-2019%22
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