FDA Medical Device Recalls (openFDA)
Philips Medical Systems: Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02
- Recall number
- Z-0063-05
- Recalling firm
- Philips Medical Systems
- Product
- Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02
- Status
- Terminated
- Initiated
- 2004-10-13
- Posted
- 2004-11-02
- Terminated
- 2012-05-15
- Reason
- Software can generate printed ECG's that associate incorrect patient data with the waveform
- 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
- 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,
- Lot, serial or model codes
- Software Versions A.01.01 or A.01.02
- 510(k) numbers
- ["K020708"]
- PMA numbers
- not on file
- Product code
- DPS
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28