Philips Medical Systems Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02
Brand
Philips Medical Systems
Lot Codes / Batch Numbers
Software Versions A.01.01 or A.01.02
Products Sold
Software Versions A.01.01 or A.01.02
Philips Medical Systems is recalling Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02 due to Software can generate printed ECG's that associate incorrect patient data with the waveform. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software can generate printed ECG's that associate incorrect patient data with the waveform
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026