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.
- Company
- Philips Medical Systems
- Recall Initiated
- September 11, 2008
- Posted
- October 10, 2008
- Terminated
- February 6, 2017
- Recall Number
- Z-0100-2009
- Quantity
- 52 units
- Firm Location
- Andover, MA
Reason for Recall
Multiprint report may contain incorrect vital data for patients
Distribution
Nationwide
Lot / Code Info
M3811B software revision identified as Build 1.1.2.11d, B.02.07.
Root Cause
Software design
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.
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