Recalls / —
—#73259
Product
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.
- FDA product code
- DQA — Oximeter
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K041674
- Affected lot / code info
- M3811B software revision identified as Build 1.1.2.11d, B.02.07.
Why it was recalled
Multiprint report may contain incorrect vital data for patients
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Philips Medical Systems
- Address
- 3000 Minuteman Road, Andover, Massachusetts 01810
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2008-09-11
- Posted by FDA
- 2008-10-10
- Terminated
- 2017-02-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #73259. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.