RecallDepth

Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02

Company
Philips Medical Systems
Recall Initiated
October 13, 2004
Posted
November 2, 2004
Terminated
May 15, 2012
Recall Number
Z-0063-05
Quantity
768 units
Firm Location
Andover, MA

Reason for Recall

Software can generate printed ECG's that associate incorrect patient data with the waveform

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,

Lot / Code Info

Software Versions A.01.01 or A.01.02

Root Cause

Other

Action Taken

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.

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