Philips SureSigns VSV (Vital Signs Viewer), 863067 recallZ-2892-2018 · Philips Electronics North America Corporation · initiated Jul 13, 2018

Why it was recalled

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.

FDA root cause category: Labeling design

What the company is doing

On July 13, 2018, the firm issued an "URGENT-Medical Device Correction" letter dated July 10, 2018, to affected customers to advise them that that monitors with batteries that have exceeded their specified replacement interval may overheat or ignite. The firm issued a Service Guide addendum included with the letter, which contains information to assist with managing the battery and its replacement. Customers were advised to do the following: Upon receipt of this notification, carefully read the enclosed SureSigns Addendum to the Service Guide. VS Series Customers -Addendum to the Service Guide: 453564807541 VM Series Customers -Addendum to the Service Guide: 453564807551 VSV Customers- Addendum to the Service Guide: 453564815301 Promptly perform the Battery Maintenance that is called out in the Addendum for each of your affected Philips SureSigns VS & VM Monitors and View Station (VSV) by determining if the Battery Information Screen indicates if the battery cycle count exceeds the limit of 300 cycles, or the battery is older than three (3) years. If so, the battery needs to be replaced. The replacement battery can be ordered using the standard Philips replacement processes. Details on how to replace the battery can be found in the Philips SureSigns VS & VM Monitors and View Station (VSV) Service Guide. Review this information with all staff members who are responsible for device management of the Philips SureSigns VS & VM Monitors and View Station (VSV). Please store the below Service Guide Addendum with your Philips SureSigns VS & VM Monitors and View Station (VSV) Service Guide documentation. VS Series Customers -Addendum to the Service Guide: 453564807541 VM Series Customers -Addendum to the Service Guide: 453564807551 VSV Customers- Addendum to the Service Guide: 453564815301 Complete and return the response card provided. In addition to providing the Service Guide Addendum and this notice, Philips plans to release a customer ins

Recall details

Recall number

Z-2892-2018

Status

Open, Classified

Initiated by the company

Jul 13, 2018

Recalling firm

Philips Electronics North America Corporation

Quantity

VM 96,324 Units; VS 110,424 Units; VSV 691 Units

Product code

MHX

FDA submissions

K070588

Distribution

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.

Product description

Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric and neonatal patients to gain information for the treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• SureSigns VSV Vital Signs ViewStation

  Philips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 80645).

• Z-2894-2018 · Open, Classified
  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 …
• Z-2895-2018 · Open, Classified
  Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitor…