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Terminated

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 Recall Z-0100-2009 · Posted 2008-10-10

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeDQA
Date Initiated2008-09-11
Date Terminated2017-02-06
Product Quantity52 units

Reason for Recall

Multiprint report may contain incorrect vital data for patients

Firm Action

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

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041674THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNITPhilips Medical Systems · 2004-07-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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