TAPSYSTEM Model 2A, REF 8002A
FDA Recall Z-1976-2019 · Posted None
Recalling FirmCardiocommand Inc.
Recall StatusTerminated
Product CodeLPA
Date Initiated2019-06-24
Date Terminated2021-04-01
Product Quantity6 units
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.
Firm Action
On June 24, the firm plans to send URGENT MEDICAL DEVICE letters to six consignees that will advise them of the issue, request that they either return their device or perform an ON/OFF switch verification procedure, and to return the attached REPLY FORM.
Root Cause
Process control
Distribution Pattern
United States - AR, NM, PA, TX, and WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.