Date Initiated by Firm | March 05, 2007 |
Date Posted | April 04, 2007 |
Recall Status1 |
Terminated 3 on August 29, 2007 |
Recall Number | Z-0716-2007 |
Recall Event ID |
37642 |
Product Classification |
electrocardiogram machine - Product Code LOS
|
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. |
Code Information |
Serial numbers: 3405AB0118E, 3605AU0168O, 3605AU0184O, 2505AB0068E, 2306AU0600E-BT, 2406AU0610E-BT, 2306AU0601E-BT, and 2707AU0641E-BT. |
Recalling Firm/ Manufacturer |
Pulse Biomedical Inc 1305 Catfish Ln Norristown PA 19403-2500
|
For Additional Information Contact | Saleem Hasan 610-666-5510 |
Manufacturer Reason for Recall | No 510(k) marketing clearance for the product |
FDA Determined Cause 2 | 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 |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|