Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02
FDA device recall Z-0063-05 · posted 2004-11-02 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Software can generate printed ECG's that associate incorrect patient data with the waveform
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 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
- Date initiated
- 2004-10-13
- Date posted
- 2004-11-02
- Date terminated
- 2012-05-15
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES (K020708) | Philips Medical Systems, Inc. | 2002-04-25 |