Z-2369-2008

Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B) Revision...

Name: Z-2369-2008 Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B) Revision...
Creator: Philips Medical Systems
Published: 2008-07-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-07-22 / Terminated / root cause: software

FDA source

Philips Medical Systems began a recall of Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B) Revision: B.02.07 Prescriptive medical device used to... on 2008-07-22. The reason FDA records is "Software: If Weight Limits edited, values will return to default values that were deleted". 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-2369-2008
Status: Terminated
Initiated: 2008-07-22
Posted: 2008-09-18
Terminated: 2012-05-16
Recalling firm: Philips North America LLC
Product: Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B) Revision: 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: Software: If Weight Limits edited, values will return to default values that were deleted
Root cause tag: software
FDA root cause: Software design
Action: Affected customers will receive the Urgent Medical Device Correction notification on 7/22/08 via certified mail. Delivery receipt will be tracked. The Urgent Medical Device Correction notification instructs customers to verify that daily and weekly weight limits are set or not set as intended while they await the correction, which will come in the form of a new version of software and will simultaneously update all systems. Philips has corrected the software defect and is in the process of validating the correction and releasing the corrected software as part of a scheduled release. If further information or support is needed, customers should contact the Telehealth Customer Service Line at 1-866-246-7316.
Quantity in commerce: 49 units
Distribution: Nationwide Distribution.
Product codes and lots: Software Revision: 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)