Data Foundry

Medical device recalls 2019

TAPSYSTEM Model 2A — Class III medical device recall Z-1976-2019

Terminated recall by Cardiocommand Inc., reported 2019-07-24, distributed in AR, NM, PA, TX, WA. There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power s

Recall numberZ-1976-2019
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCardiocommand Inc., Tampa, FL, United States
Recall initiated2019-06-24
Classified2019-07-15
Reported by FDA2019-07-24
Terminated2021-04-01
DistributedAR, NM, PA, TX, WA
Quantity6 units
Serial numbers2196A, 2197A, 2198A, 2199A, 2200A, 2201A
Model numbers8002A

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1976-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.