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 monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patient
Check against the official notice below — it lists the full affected range.
Philips is recalling certain SureSigns VM and VS patient monitors and View Station devices worldwide due to a risk of lithium ion battery overheating or ignition. The batteries in these devices are designed to be replaced every 3 years or after 300 charge-discharge cycles, but the devices' labeling does not provide complete instructions on how to use the displayed battery age and charge-cycle information to determine when replacement is needed. If a battery exceeds its safe lifespan, it may overheat and cause the device case to overheat, melt, or ignite, potentially injuring patients or nearby users or causing property damage.
The recall affects approximately 207,439 patient monitors and View Stations that have been distributed worldwide, including throughout the United States, Puerto Rico, and numerous other countries. The source document does not specify a remedy or corrective action 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#'s VM3 (863077): 00884838028791 VM4 (863063): 00884838000032, (863085): 00884838028807 VM6 (863064): 00884838000049, (863065): 00884838000056, (863086): 00884838028814 VM8 (863066): 00884838000063, (863068): 00884838000087, (863087): 00884838028821, (863088): 00884838028838, (863317): 00884838050464
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.