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Terminated

QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine.

FDA Recall Z-0716-2007 · Posted 2007-04-04

Recalling FirmPulse Biomedical Inc
Recall StatusTerminated
Product CodeLOS
Date Initiated2007-03-05
Date Terminated2007-08-29
Product Quantity8 units

Reason for Recall

No 510(k) marketing clearance for the product

Firm Action

On 3/5/07, the recalling firm telephoned their customers to inform them of the problem and the need to return to the product. As a follow up to the telephone calls a letter dated 3/5/07 was sent via certified mail.

Root Cause

Other

Distribution Pattern

The product was shipped to four direct customers in CA, NY, TN and US military (Cuba). The product was also shipped to Chile, Greece, and the Netherlands

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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