FDA Medical Device Recalls (openFDA)
Philips Medical Systems: 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.
- Recall number
- Z-1911-2008
- Recalling firm
- Philips Medical Systems
- 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.
- Status
- Terminated
- Initiated
- 2008-04-30
- Posted
- 2008-09-16
- Terminated
- 2017-03-29
- Reason
- 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
- 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
- 7,529 units
- Distribution
- Worldwide Distribution to United States, Canada and Foreign countries
- Lot, serial or model codes
- SureSigns VS3; Model numbers 863071, 863072, 863073, 863074
- 510(k) numbers
- ["K052707"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28