Z-0716-2007

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

Name: Z-0716-2007 QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0)...
Creator: Pulse Biomedical Inc
Published: 2007-03-05
License: https://open.fda.gov/license/

Pulse Biomedical, Inc. / initiated 2007-03-05 / Terminated

FDA source

Pulse Biomedical Inc began a recall of QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine on 2007-03-05. The reason FDA records is "No 510(k) marketing clearance for the product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0716-2007
Status: Terminated
Initiated: 2007-03-05
Posted: 2007-04-04
Terminated: 2007-08-29
Recalling firm: Pulse Biomedical, Inc.
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
Reason for recall: No 510(k) marketing clearance for the product
FDA root cause: Other
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.
Quantity in commerce: 8 units
Distribution: 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
Product codes and lots: Serial numbers: 3405AB0118E, 3605AU0168O, 3605AU0184O, 2505AB0068E, 2306AU0600E-BT, 2406AU0610E-BT, 2306AU0601E-BT, and 2707AU0641E-BT.

Product code LOS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)