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 o
Check against the official notice below — it lists the full affected range.
Philips has recalled Philips SureSigns VS, VM, and VSV vital signs monitors due to a hazard involving their lithium ion batteries. The company received reports of batteries that exceeded their expected lifespan overheating or igniting. These batteries should be replaced every 3 years or after 300 charge-discharge cycles, but the device labeling does not provide complete instructions on how to use the battery age and charge-cycle information displayed on the monitors to determine when replacement is necessary. 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 other countries. The source document does not specify a remedy or instructions 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# VSV (863067): 00884838009578
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.