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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare SureSigns VS2

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 Class 2 Device Recall Philips Healthcare SureSigns VS2 see related information
Date Posted February 14, 2013
Recall Status1 Open
Recall Number Z-0824-2013
Recall Event ID 64070
510(K)Number K112652 
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
Product Philips Healthcare SureSigns VS2+
Model 863278 SureSigns VS2+ NBP and SpO2
Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature

Product Usage:
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.
Code Information 02500, CN21202501, CN21202502, CN21202503, CN21202504, CN21202505, CN21202506, CN21202507, CN21202508, CN21202509, CN21202510, CN21202511, CN21202512, CN21202513, CN21202514, CN21202670, CN21202671, CN21202672, CN21202673, CN21202674, CN21202675, CN21202681, CN21202682, CN21202684, CN21202685, CN21202686, CN21202687, CN21202841, CN21203031, CN21203046, CN21203047, CN21203048, CN21203049, CN21203050, CN21203051, CN21203052, CN21203053, CN21203074, CN21203075, CN21203076, CN21203077, CN21203078, CN21203079, CN21203080, CN21203081, CN21203082, CN21203083, CN21203084, CN21203085, CN21203086, CN21203087, CN21203088, CN21203089, CN21203090, CN21203091, CN21203092, CN21203093, CN21203094, CN21203095, CN21203154, CN21203155, CN21203156, CN21203157, CN21203189, CN21203190, CN21203191, CN21203192, CN21203193, CN21203194, CN21203214, CN21203215, CN21203216, CN21203217, CN21203218, CN21203219, CN21203220, CN21203221, CN21203232, CN21203233, CN21203234, CN21203235, CN21203236, CN21203237, CN21203238, CN21203239, CN21203240, CN21203241, CN21203242, CN21203243, CN21203244, CN21203245, CN21203246, CN21203247, CN21203248, CN21203249, CN21203250, CN21203251, CN21203252, CN21203290, CN21203291, CN21203292, CN21203293, CN21203294, CN21203295, CN21203296, CN21203297, CN21203323, CN21203324, CN21203337, CN21203338, CN21203339, CN21203363, CN21203383, CN21203384, CN21203385, CN21203386, CN21203387, CN21203393, CN21203394, CN21203395, CN21203396, CN21203397, CN21203404, CN21203405, CN21203406, CN21203407, CN21203408, CN21203409, CN21203410, CN21203411, CN21203412, CN21203413, CN21203414, CN21203417, CN21203462, CN21203463, CN21203464, CN21203465, CN21203466, CN21203467, CN21203636, CN21203709, CN21203710, CN21203711, CN21203712, CN21203741, CN21203750, CN21203751, CN21203752, CN21203753, CN21203829, CN21203830, CN21203831, CN21203832, CN21203833, CN21203834, CN21203835, CN21203836, CN21203837, CN21203838, CN21203871, CN21203872, CN21203873, CN21203874, CN21203875, CN21203876, CN21203877, CN21203878, CN21203879, CN21203880, CN21203881, CN21203882, CN21203883, CN21203884, CN21203885, CN21203900, CN21203901, CN21203902, CN21203903, CN21203904, CN21203905, CN21203906, CN21203907, CN21203908, CN21203909, CN21203910, CN21203911, CN21203912, CN21203913, CN21203914, CN21203915, CN21203916, CN21203917, CN21203918, CN21203919, CN21203920, CN21203921, CN21203922, CN21203923, CN21203954, CN21203955, CN21203956, CN21203957, CN21203958, CN21203962, CN21203963, CN21203964, CN21203971, CN21203972, CN21203973, CN21203974, CN21203975, CN21203976, CN21203977, CN21203978, CN21203979, CN21203980, CN21203981, CN21203982, CN21203983, CN21203984, CN21203995, CN21203996, CN21203997, CN21203998, CN21204006, CN21204012, CN21204014, CN21204015, CN21204123, CN21204124, CN21204212, CN21204213, CN21204216, CN21204217, CN21204275, CN21204276, CN21204277, CN21204278, CN21204279, CN21204280, CN21204281, CN21204282, CN21204316, CN21204326, CN21204327, CN21204328, CN21204373, CN21204374, USPP3NCK10
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Debra Levasseur
978-659-4065
Manufacturer Reason
for Recall
VS2+ screen may lock up and stop monitoring during patient use
FDA Determined
Cause 2
Software design
Action Philips issued an Urgent Medical Device Correction letter on January 14, 2013. The field action will take place in two phases: Phase 1 Philips sent customer an Urgent Medical Device Correction Notification/Field Safety Notice. This notification explains the issues and gives the customers instructions on actions to take while they await the hardware correction. Phase 2 Once the hardware correction Philips will contact customers and perform the correction free of charge. Until the correction is available. Affected products may continue to be used while waiting for the correction from Philips if the unit is not used in NBP interval mode. A Philips Healthcare representative will contact you to arrange for the correction of all affected devices. If you need any further information or support concerning this issue, please contact the Philips Customer Care Center at 1-800-722-9377. On 3/14/13, firm stated Initially the fix would be a hardware upgrade but have since changed that to a software update. Customers within the US will be sent a new Field Safety Notice as well as a USB software update package and will be required to notify us upon the upgrade of their affected units. They will be performing the updates themselves
Quantity in Commerce 3248 units
Distribution Worldwide Distribution - US Nationwide and the countries of: AUSTRALIA, AUSTRIA, BELGIUM,CANADA, CHILE, DENMARK, FRANCE GERMANY, ICELAND, INDIA, IRELAND,ISRAEL,ITALY, JORDAN, KENYA KUWAIT, LEBANON, MALAYSIA, NAMIBIA, NETHERLANDS, NEW ZEALAND NORWAY,PALESTINE, POLAND,PORTUGAL, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH AFRICA, SOUTH KOREA,SPAIN,SWEDEN, SWITZERLAND THAILAND, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES UNITED KINGDOM
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DXN and Original Applicant = PHILIPS MEDICAL SYSTEMS
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