Company:Philips Healthcare Inc
Date of Enforcement Report 1/27/2010
Class:ll
PRODUCT
1) SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4″display VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedside Patient Monitor with 8.4″ display VM6 3/5 Lead ECG, NBP, Temp, optional SPo2 Bedside Patient Monitor with 8.4″ display or 3/5 Lead ECG, NBP, Temp, optional SPo2 option IBP Bedside Patient Monitor with 8.4″ display VM8 3/5 Lead ECG, NBP, Temp, IPB, ET CO2, SPo2 Bedside Patient Monitor with 10″ display or 3/5 Lead ECG, NBP, Temp, IPB, SPo2 Bedside Patient Monitor with 10″ display Part number: VM3: 863077, 453564041661, 453564050161, VM4: 863063, 453564024371, 453564021961, 453564024401, 453564021971 VM6: 863064,863065, 453564024421, 453564022001, 453564024441 VM8: 453564022041, 863066, 863068, 453564022081, 453564024461, 453564024481 The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. Recall # Z-0372-2010;
2) SureSigns Vital Signs Monitors (VS3)-Vital Signs Viewer Central Viewing Station View up to 12 VM monitors at 1 time Part number: 863069, 863070, 63071, 863072, 863073, 863074, 453564041251, 453564041261, 453564041271, 453564041281, 453564041291, 453564041301 The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. Recall # Z-0373-2010;
3) SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to include Predictive Temperature only; SPo2 only; SPo2 and Recorder only; SPo2 and Predictive Temperature only; or SPo2, Predictive Temperature, and Recorder Part Number: 863067 and 453564041491 The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. Recall # Z-0374-2010
REASON
Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker.
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter dated October 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
49,648 units
DISTRIBUTION
Nationwide and Internationally.
