Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameter of patients. Standard and optional parameters include: NBP, Sp02, Temperature. Th
Check against the official notice below — it lists the full affected range.
Philips is recalling SureSigns VS2 vital signs monitors used by healthcare professionals because lithium ion batteries that have exceeded their intended lifespan can overheat or ignite. These batteries should be replaced every 3 years or after 300 charge-discharge cycles. While the monitors can display battery age and charge cycles, the current labeling does not provide complete instructions on how to use this information to determine when replacement is needed. An overheated battery can cause the device case to overheat, melt, or ignite, potentially injuring patients or nearby users or damaging property.
The recall affects approximately 207,439 monitors distributed worldwide, including throughout the United States, Puerto Rico, and numerous countries. The record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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, Quantity: VM 96,324 Units; VS 110,424 Units; VSV 691 Units Lot/code info: UDI# VS2 (863079): 00884838009639, (863080): 00884838009646, (863081): 00884838009653, (863082): 00884838009660
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.