Pulse Biomedical Inc QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Pulse Biomedical Inc
Lot Codes / Batch Numbers
Serial numbers: 3405AB0118E, 3605AU0168O, 3605AU0184O, 2505AB0068E, 2306AU0600E-BT, 2406AU0610E-BT, 2306AU0601E-BT, and 2707AU0641E-BT.
Products Sold
Serial numbers: 3405AB0118E, 3605AU0168O, 3605AU0184O, 2505AB0068E, 2306AU0600E-BT, 2406AU0610E-BT, 2306AU0601E-BT, and 2707AU0641E-BT.
Pulse Biomedical Inc is recalling QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite due to No 510(k) marketing clearance for the product. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
No 510(k) marketing clearance for the product
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN, NY, TN
Page updated: Jan 10, 2026