Recall Z-2895-2018— Philips Electronics North America Corporation
Class II · Ongoing
Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2018-07-13. It names 2 FDA 510(k) clearances: K123900, K080495. Product: 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 patients. Standard and optional parameters include: " ECG " Respiration " NBP " S2pO " IBP " CO2 " Temperature. Reason: 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..
- Recalling firm
- Philips Electronics North America Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-07-13
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K123900 — SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
- K080495 — SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 patients. Standard and optional parameters include: " ECG " Respiration " NBP " S2pO " IBP " CO2 " Temperature
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.