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U.S. Department of Health and Human Services

Class 2 Device Recall Philips SureSigns Patient Monitors

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  Class 2 Device Recall Philips SureSigns Patient Monitors see related information
Date Initiated by Firm October 30, 2009
Date Posted November 23, 2009
Recall Status1 Terminated 3 on February 20, 2013
Recall Number Z-0372-2010
Recall Event ID 53688
510(K)Number K090483  
Product Classification Electrocardiograph - Product Code MHX
Product 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.
Code Information Software Versions: A.01.51, A.01.45, A.01.42, A.01.40, A.00.58, A.00.55, A.00.52, A.00.51, and A.00.41
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		 Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker
FDA Determined
Cause 2		 Software design
Action Customer notifications dated October 2009, in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. Customers will be instructed to lower the volume setting while using existing units during the first notification. As part of the second notification to the customers, the field action correction will be a customer installable software upgrade. Customers may contact Philips Response Center with questions or concerns at 1.800.722.9377. On December 14, the firm issued the follow-up notification letter implementing the action plan to provide the software upgrade kit for installation and instructions.
Quantity in Commerce 30, 833 units
Distribution Nationwide Foreign: Canada Afghanistan, Albania, Algeria, Angola, Argentina, Austria, Australia, Bahrain, Bosnia & Herzegowina, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, Ghana, Great Britain, French Guiana, Guadeloupe, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iceland, Italy, Iraq, Jordan, Japan, Jamaica Republic of Korea, Kenya, Kosovo, Kuwait, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Libyan Arab Jamahiriya, Morocco, Norway, New Zealand, Republic of Moldova, Macau, Malawi, Mali, Malta, Martinique, Mauritius, Mexico, Malaysia, Namibia, Nepal, Netherlands,Nicaragua, Nigeria, Norway, Philippines, Pakistan, Oman, Panama, Peru, Poland, Puerto Rico, Palestinian Territories, Portugal, Qatar, Romania, Republic of Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Spain, Sri Lanka, Switzerland, El Salvador, Tanzania, Thailand, Tunisia, Turkey, Taiwan, Uganda, Venezuela, Vietnam, South Africa, and Zimbabwe United Arab Emirates
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS
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