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Recall Observatory FDA recall evidence

Device product

TAPSYSTEM Model 2A, REF 8002A

Z-1976-2019

June 24, 2019

Class III

Product summary

Firm
Cardiocommand Inc.
Event
Event 83173
Status
Terminated
Classification
Class III
Quantity
6 units
Official record key
device-enforcement:Z-1976-2019

Official wording

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

Code information: SERIAL NUMBERS: 2197A, 2196A, 2198A, 2199A, 2200A, and 2201A,

Distribution pattern: United States - AR, NM, PA, TX, and WA.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    assembly error