CLASS II ONGOING Device recall · Reported 29 Aug 2018 · FDA Enforcement Report

Philips SureSigns VS4 Vital Signs Monitor recalled

Philips Electronics North America is recalling Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs, distributed nationwide in the US. The recall was initiated on 13 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI# VS4 (863283): 00884838087095

Quantity recalledVM 96,324 Units; VS 110,424 Units; VSV 691 Units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2894-2018
FDA event ID: 80645
Recalling firm: Philips Electronics North America, Andover, MA
Classification: Class II
Status: Ongoing
Recall initiated: 13 Jul 2018
FDA classified: 22 Aug 2018
Reported: 29 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

13 Jul 2018	Recall initiated by company
22 Aug 2018	Classified by FDA	+40 days
29 Aug 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 monitor is for monitoring, recording, and alarming of multiple physiological parameters in healthcare environments for the patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

Where it was distributed

Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Afghanistan, Albania, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Canada, Cambodia, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Czech Republic, Dominican Republic, El Salvador, Egypt, Estonia, Ethiopia, France, French Guiana, French Polynesia, Finland, Guadeloupe, Germany, Ghana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kenya, Korea, Kosovo, Republic of, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Lybia, Macao, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, State of, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Zambia and Zimbabwe.

Nationwide Puerto Rico

Questions about this recall

Is Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs recalled?

Yes. Philips Electronics North America recalled Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs on 13 Jul 2018. The recall is Class II and its status is Ongoing. Recall number Z-2894-2018.

Why was it recalled?

Which lots are affected?

UDI# VS4 (863283): 00884838087095

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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