Philips Healthcare Inc.: Philips SureSigns VS3 Vital Signs Monitor Models: VS3 863069, 863070, 453564041251, 453564041261, VS3 863071, 863072, 863073, 863074, 453564041271, 453564041281, 453564041291, 453564041301 The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

Recall number

Z-2584-2011

Recalling firm

Philips Healthcare Inc.

Product

Philips SureSigns VS3 Vital Signs Monitor Models: VS3 863069, 863070, 453564041251, 453564041261, VS3 863071, 863072, 863073, 863074, 453564041271, 453564041281, 453564041291, 453564041301 The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

Status

Terminated

Initiated

2011-06-10

Posted

2011-06-17

Terminated

2013-08-15

Reason

Speakers on the SureSigns Patient Monitors and Vital Signs, failure may be identified by the display of a Speaker Malfunc message in the alarm message area or an AUDIO FAILED message in the main screen of the device or by the absence of audible sound

Root cause

Device Design

Action

Philips Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 2011 to all affected customers. The letter identifies the products, problem, and actions to be taken. The letter states that customers may continue to use the affected products while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP. Additionally, the letter states that if the customer experience this INOP or there is no sound from the SureSigns Monitor, the customer is to remove the device from use and contact their local Philips service representative. The letter explains that Philips is completing the design for a replacement speaker assembly, which is expected to be available within 8 weeks. When available, Philips will replace the affected speaker assemblies free of charge. Customers are instructed to contact their local Philips Customer Care Center at 1-800-722-9377 if further information or support is required.

Quantity

5225 units

Distribution

Worldwide Distribution--USA (nationwide) and countries of ARAB JAMAHIRI, AUSTRIA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, CANADA ,CHILE, COLOMBIA, CROATIA, CYPRUS, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, KUWAIT, LEBANON, LIBYAN, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA ,SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.

Lot, serial or model codes

Serial Number Range CN04400000 - CN04499999 US10200000 - US10299999 CN03700000 - CN03799999 CN04400000 - CN04499999 CN10200000 - CN10299999 US03800000 - US03899999 US04400000 - US04499999 US10200000 - US10299999

510(k) numbers

["K090483"]

PMA numbers

not on file

Product code

DPS

Firm FEI

1218950

Firm city

Andover

Firm state

MA

Firm country

not on file

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

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