Enforcement Report - Week of September 5, 2012
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Event Detail
| Event ID | 62865 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Philips Healthcare Inc. |
| City | Andover |
| State | MA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-15 |
| Initial Firm Notification of Consignee or Public | Letter |
| 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. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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 | Serial Number Range CN14800101-CN14801360 CN21201362-CN21202440, CN21202525, SP13701043, USPP101007 | Class II | Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount | 2314 units | Z-2303-2012 |
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