Z-0100-2009

M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A...

Name: Z-0100-2009 M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A...
Creator: Philips Medical Systems
Published: 2008-09-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-09-11 / Terminated / root cause: software

FDA source

Philips Medical Systems began a recall of M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision identified as Build 1.1.2.11d, B.02.07... on 2008-09-11. The reason FDA records is "Multiprint report may contain incorrect vital data for patients". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0100-2009
Status: Terminated
Initiated: 2008-09-11
Posted: 2008-10-10
Terminated: 2017-02-06
Recalling firm: Philips North America LLC
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.
Product code: DQA Oximeter
Reason for recall: Multiprint report may contain incorrect vital data for patients
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 52 units
Distribution: Nationwide
Product codes and lots: M3811B software revision identified as Build 1.1.2.11d, B.02.07.

Product code DQA

K041674Class IIThe M3810a Philips Telemonitoring System with M3814a Spo2 UnitPhilips Medical Systems / cleared 2004-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)