FDA Recall
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.
Recall: Z-0716-2007
·
Initiated March 5, 2007
Recall
- Recall Number
- Z-0716-2007
- Event Number
- 37642
- Firm
- Pulse Biomedical Inc
- FEI Number
- 1000121413
- Product Code
- LOS
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 5, 2007
- Posted
- April 4, 2007
- Terminated
- August 29, 2007
- Address
- 1305 Catfish Ln, Norristown, PA, 19403-2500
Description
QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine.
Reason
No 510(k) marketing clearance for the product
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.
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
Quantity
8 units