Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B) Revision: B.02.07 Presc
FDA device recall Z-2369-2008 · posted 2008-09-18 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Software: If Weight Limits edited, values will return to default values that were deleted
- Action taken
- 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 further information or support is needed, customers should contact the Telehealth Customer Service Line at 1-866-246-7316.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 49 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-07-22
- Date posted
- 2008-09-18
- Date terminated
- 2012-05-16
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT (K041674) | Philips Medical Systems | 2004-07-19 |