M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision
FDA device recall Z-0100-2009 · posted 2008-10-10 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Multiprint report may contain incorrect vital data for patients
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 52 units
- Distribution
- Nationwide
- Date initiated
- 2008-09-11
- Date posted
- 2008-10-10
- Date terminated
- 2017-02-06
- 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 |
|---|---|---|
| THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT (K041674) | Philips Medical Systems | 2004-07-19 |