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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare

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  Class 2 Device Recall Philips Healthcare see related information
Date Initiated by Firm June 10, 2011
Date Posted June 17, 2011
Recall Status1 Terminated 3 on August 15, 2013
Recall Number Z-2583-2011
Recall Event ID 59037
510(K)Number K101067  
Product Classification Monitor, physiological, patient (with arrhythmia detection or alarms) - Product Code MHX
Product Philips SureSigns VM Series Patient Monitors:
VM4, VM6, VM 8:
Model Part Numbers
VM4 863063, 453564024371, 453564021961, 453564024401, 453564021971
VM6 863064, 863065, 453564024421, 453564022001, 453564024441, 453564022041
VM8 863066, 863068, 453564022081, 453564024461, 453564024481

The SureSigns VS3 vital signs monitor and 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. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are 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 Serial Number Range US11149477 - US11149503 US11149741 - US11149795 US11149798 - US11149883 US11149886 - US11149932 US11149935 - US11149959 US11149961 - US11149967 US11150078 - US11150124 US11150162 - US11150177 US11150196 - US11150307 US11150312 - US11150315 US11150336 - US11150343 US11150345 - US11150546   
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Same
978-687-1501
Manufacturer Reason
for Recall		 Speakers on the SureSigns Patient Monitors and Vital Signs, failure may be identified by the display of a Speaker Malfunc message in the alarm message area or an AUDIO FAILED message in the main screen of the device or by the absence of audible sound
FDA Determined
Cause 2		 Device Design
Action Philips Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 2011 to all affected customers. The letter identifies the products, problem, and actions to be taken. The letter states that customers may continue to use the affected products while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP. Additionally, the letter states that if the customer experience this INOP or there is no sound from the SureSigns Monitor, the customer is to remove the device from use and contact their local Philips service representative. The letter explains that Philips is completing the design for a replacement speaker assembly, which is expected to be available within 8 weeks. When available, Philips will replace the affected speaker assemblies free of charge. Customers are instructed to contact their local Philips Customer Care Center at 1-800-722-9377 if further information or support is required.
Quantity in Commerce 515 units
Distribution Worldwide Distribution--USA (nationwide) and countries of ARAB JAMAHIRI, AUSTRIA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, CANADA ,CHILE, COLOMBIA, CROATIA, CYPRUS, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, KUWAIT, LEBANON, LIBYAN, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA ,SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
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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