—#111900

Product

Philips 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

FDA product code: DXN — System, Measurement, Blood-Pressure, Non-Invasive
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K112652
Affected lot / code info: Serial Number Range CN14800101-CN14801360 CN21201362-CN21202440, CN21202525, SP13701043, USPP101007

Why it was recalled

Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount

Root cause (FDA determination)

Process design

Action the firm took

Philips 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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide 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.

Timeline

Recall initiated: 2012-08-15
Posted by FDA: 2012-08-30
Terminated: 2014-03-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111900. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.