Recall Z-0124-2008 ยท DPS Electrocardiograph
Philips Medical Systems
Philips PageWriter Touch Cardiograph, Model: 860284, Philips Medical Systems, Andover, MA, 01810
| Date | Jan 30, 2008 (initiated Sep 12, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software change control |
| Action | 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. |
| Quantity | 266 units |
| Distribution | Worldwide Distribution - USA, Canada, Australia, Hungary, New Zealand, Nigeria, Norway, Qatar, Taiwan, and UAE. |
| 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 |