Recall Z-2369-2008 ยท DQA Oximeter
Philips Medical Systems
Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B) Revision: 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 | Sep 18, 2008 (initiated Jul 22, 2008) |
| Status | Terminated |
| Reason | Software: If Weight Limits edited, values will return to default values that were deleted |
| Root cause | Software design |
| Action | Affected customers will receive the Urgent Medical Device Correction notification on 7/22/08 via certified mail. Delivery receipt will be tracked. The Urgent Medical Device Correction notification instructs customers to verify that daily and weekly weight limits are set or not set as intended while they await the correction, which will come in the form of a new version of software and will simultaneously update all systems. Philips has corrected the software defect and is in the process of validating the correction and releasing the corrected software as part of a scheduled release. If furth |
| Quantity | 49 units |
| Distribution | Nationwide Distribution. |
| 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 |