Recall Z-0716-2007 ยท LOS
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.
| Date | Apr 4, 2007 (initiated Mar 5, 2007) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.