Z-1911-2008

Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 863074. All...

Name: Z-1911-2008 Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 863074. All...
Creator: Philips Medical Systems
Published: 2008-04-30
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-04-30 / Terminated / root cause: labeling and UDI

FDA source

Philips Medical Systems began a recall of Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 863074. All four model numbers have the same user manual. The... on 2008-04-30. The reason FDA records is "Some users of SureSigns VS3 Signs Monitor may have assumed that the SpO2 Non-Pulsatile and SpO2 No Sensor technical alarms were enabled when the SureSigns VS3 Vital Signs Monitor was not in Interval non-invasive blood...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1911-2008
Status: Terminated
Initiated: 2008-04-30
Posted: 2008-09-16
Terminated: 2017-03-29
Recalling firm: Philips North America LLC
Product: Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 863074. All four model numbers have the same user manual. The device is intended for monitoring, recording and alarming of multiple physiological parameters.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Some users of SureSigns VS3 Signs Monitor may have assumed that the SpO2 Non-Pulsatile and SpO2 No Sensor technical alarms were enabled when the SureSigns VS3 Vital Signs Monitor was not in Interval non-invasive blood pressure (NBP) mode. These alarms are only enabled when interval NBP mode is selected. If when monitoring SpO2, the clinician does not notice when the sensor is no longer attached, the patient is not being monitored through Spo2.This could result in delay or lack of needed therapy. The labeling provided with the monitor did not fully describe this feature.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: All affected customers will receive the FSN (Field Safety Notice )informing them about the labeling correction. Included with the FSN will be an addendum to the instructions for use. customers are asked to read the addendum and insert a copy into each of their copies of the VS3 instructions for use. Customers will also receive a Medical Device Correction Confirmation Card that they will be asked to fill out and fax back to their local Philips representative. Contact your local Philips support organization at 1-800-722-9377 in the United States or 1-800-323-2280 in Canada.
Quantity in commerce: 7,529 units
Distribution: Worldwide Distribution to United States, Canada and Foreign countries
Product codes and lots: SureSigns VS3; Model numbers 863071, 863072, 863073, 863074

Product code MHX

K052707Class IIM3046b Compact Portable Patient MonitorsPhilips Medical Systems / cleared 2005-10-20

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)