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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) interfacesee related information
Date Initiated by FirmMarch 05, 2007
Date PostedApril 04, 2007
Recall Status1 Terminated 3 on August 29, 2007
Recall NumberZ-0716-2007
Recall Event ID 37642
Product Classification electrocardiogram machine - Product Code LOS
ProductQRS 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 ContactSaleem Hasan
610-666-5510
Manufacturer Reason
for Recall		No 510(k) marketing clearance for the product
FDA Determined
Cause 2		Other
ActionOn 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 Commerce8 units
DistributionThe 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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