Z-0063-05

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

Name: Z-0063-05 Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02
Creator: Philips Medical Systems
Published: 2004-10-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2004-10-13 / Terminated / root cause: software

FDA source

Philips Medical Systems began a recall of Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02 on 2004-10-13. The reason FDA records is "Software can generate printed ECG's that associate incorrect patient data with the waveform". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0063-05
Status: Terminated
Initiated: 2004-10-13
Posted: 2004-11-02
Terminated: 2012-05-15
Recalling firm: Philips North America LLC
Product: Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02
Product code: DPS Electrocardiograph
Reason for recall: Software can generate printed ECG's that associate incorrect patient data with the waveform
Root cause tag: software
FDA root 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,
Product codes and lots: Software Versions A.01.01 or A.01.02

Product code DPS

K020708Class IIPhilips Pagewriter Touch Cardiograph, Model M5000a SeriesPhilips Medical Systems, Inc. / cleared 2002-04-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)