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Class 2 Device Recall |
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Date Initiated by Firm |
October 13, 2004 |
Date Posted |
November 02, 2004 |
Recall Status1 |
Terminated 3 on May 15, 2012 |
Recall Number |
Z-0063-05 |
Recall Event ID |
30210 |
510(K)Number |
K020708
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Product Classification |
Electrocardiograph - Product Code DPS
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Product |
Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02 |
Code Information |
Software Versions A.01.01 or A.01.02 |
Recalling Firm/ Manufacturer |
Philips Medical Systems 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact |
Brenda Getchell 978-659-2134
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Manufacturer Reason for Recall |
Software can generate printed ECG's that associate incorrect patient data with the waveform
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FDA Determined Cause 2 |
Other |
Action |
Philips notified accounts by letter on 9/13/04 and advised users of the problem and will provide the software upgrade kit to version A.01.03. |
Quantity in Commerce |
768 units |
Distribution |
Nationwide
Australia, Brazil Korea, Japan, Mexico, Singapore,Taiwan,Canada, Belgium, Germany, Lebanon, Israel, Italy, Ireland, Netherlands, Oman, Spain, Saudia Arabia,Poland, Qtar,Switzerland, UAE, UK, |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = DPS and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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