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U.S. Department of Health and Human Services

Class 2 Device Recall QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface

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  Class 2 Device Recall QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface see related information
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.
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