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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare SureSigns VSi/VS2

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 Class 2 Device Recall Philips Healthcare SureSigns VSi/VS2see related information
Date Initiated by FirmAugust 15, 2012
Date PostedAugust 30, 2012
Recall Status1 Terminated 3 on March 13, 2014
Recall NumberZ-2303-2012
Recall Event ID 62865
510(K)NumberK112652 
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
ProductPhilips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is 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. The SureSigns VSi vital signs monitor is for measurement 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 CN14800101-CN14801360  CN21201362-CN21202440, CN21202525, SP13701043, USPP101007  
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount
FDA Determined
Cause 2		Process design
ActionPhilips sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated August 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers using the VSi/VS2+ with the GCX wall mount are instructed to complete and fax a Customer Reply Wall Mount Order Card to the Business Unit or Key Market indicating the number of wall mounts in use. Upon receipt of the Customer Reply Wall Mount Order Card, Philips will send a replacement of the mounting hardware. Customers should contact their local Philips representative for questions regarding this recall.
Quantity in Commerce2314 units
DistributionWorldwide Distribution-USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, DENMARK, EL SALVADOR, FRANCE, GERMANY, ICELAND, INDIA, IRELAND ISRAEL, ITALY, JORDAN, KENYA, LEBANON, MALAYSIA,NAMIBIA NETHERLANDS, NORWAY, POLAND, PORTUGAL, RWANDA SAUDI ARABIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DXN
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