Recall Z-2303-2012 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Philips Healthcare Inc.
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
| Date | Aug 30, 2012 (initiated Aug 15, 2012) |
| Status | Terminated |
| Reason | Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount |
| Root cause | Process design |
| Action | 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 |
| Quantity | 2314 units |
| Distribution | 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 AFRIC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112652 | SURESIGNS VS2+ -SURESIGNS VSI Philips Medical Systems, Oct 11, 2011 |