—#70436

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.

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K052707
Affected lot / code info: SureSigns VS3; Model numbers 863071, 863072, 863073, 863074

Why it was recalled

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 (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide Distribution to United States, Canada and Foreign countries

Timeline

Recall initiated: 2008-04-30
Posted by FDA: 2008-09-16
Terminated: 2017-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70436. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.