Recall Z-0063-05 ยท DPS Electrocardiograph
Philips Medical Systems
Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02
| Date | Nov 2, 2004 (initiated Oct 13, 2004) |
| Status | Terminated |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020708 | PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES Philips Medical Systems, Inc., Apr 25, 2002 |