Device recall

Z-0716-2007: QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless)…

FDA device recall · Class II · Pulse Biomedical Inc

Key facts

Recall number (Z-number) Z-0716-2007
Recall event 37642
Product QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine.
Product code LOS
Recalling firm Pulse Biomedical Inc
Recall class Class II
Status Terminated
Termination date Aug 29, 2007
FEI number 1000121413

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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