Philips PageWriter Touch Cardiograph, Model: 860284, Philips Medical Systems, Andover, MA, 01810
FDA device recall Z-0124-2008 · posted 2008-01-30 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.
- Action taken
- Philips Medical Systems notified affected customers by Customer Letter and Urgent - Device Correction Notice dated 9/12/07. The correction will be a software upgrade. In the US, the Philips Response Center will contact US customers and arrange their upgrades, either via a software download, or by sending a Field Service Engineer to the customer site to perform the upgrade. Until new software is installed, customers are being advised to use the 12 lead module, and to disable or disconnect the 16 lead connection.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 266 units
- Distribution
- Worldwide Distribution - USA, Canada, Australia, Hungary, New Zealand, Nigeria, Norway, Qatar, Taiwan, and UAE.
- Date initiated
- 2007-09-12
- Date posted
- 2008-01-30
- Date terminated
- 2016-08-16
- 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 |