FDA Medical Device Recalls (openFDA)
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 number
- Z-0716-2007
- 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.
- Status
- Terminated
- Initiated
- 2007-03-05
- Posted
- 2007-04-04
- Terminated
- 2007-08-29
- Reason
- No 510(k) marketing clearance for the product
- 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
- 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
- Lot, serial or model codes
- Serial numbers: 3405AB0118E, 3605AU0168O, 3605AU0184O, 2505AB0068E, 2306AU0600E-BT, 2406AU0610E-BT, 2306AU0601E-BT, and 2707AU0641E-BT.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LOS
- Firm FEI
- 1000121413
- Firm city
- Norristown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28