Class 2 Device Recall

• Date Initiated by Firm: October 13, 2004
• Date Posted: November 02, 2004
• Recall Status: Terminated on May 15, 2012
• Recall Number: Z-0063-05
• Recall Event ID: 30210
• 510(K)Number: K020708
• Product Classification: Electrocardiograph - Product Code DPS
• Product: Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02
• Code Information: Software Versions A.01.01 or A.01.02
• FEI Number: 1218950
• Recalling Firm/ Manufacturer: Philips Medical Systems; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Brenda Getchell; 978-659-2134
• Manufacturer Reason for Recall: Software can generate printed ECG's that associate incorrect patient data with the waveform
• FDA Determined Cause: 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

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.

• 510(K) Database: 510(K)s with Product Code = DPS