Recall Z-0100-2009 ยท DQA Oximeter
Philips Medical Systems
M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision identified as Build 1.1.2.11d, B.02.07. Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient.
| Date | Oct 10, 2008 (initiated Sep 11, 2008) |
| Status | Terminated |
| Reason | Multiprint report may contain incorrect vital data for patients |
| Root cause | Software design |
| Action | Philips contacted customers by sending an Urgent Medical Device Correction Notification on 9/11/08. Letters to customers sent via certified mail and receipt of delivery will be tracked. Customers are asked to follow the Action To Be Taken By Customer/User section of the Urgent Medical Device Correction Notification. This section instructs users to allow the upgrade of the software upon logging in to the system. Contact Philips at 1-866-246-7316 for assistance. |
| Quantity | 52 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041674 | THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT Philips Medical Systems, Jul 19, 2004 |