Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02
FDA Recall Z-0063-05 · Posted 2004-11-02
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Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeDPS
Date Initiated2004-10-13
Date Terminated2012-05-15
Product Quantity768 units
Reason for Recall
Software can generate printed ECG's that associate incorrect patient data with the waveform
Firm 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.
Root Cause
Other
Distribution Pattern
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,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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