Recall Z-0824-2013 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Philips Healthcare Inc.
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 wit
| Date | Feb 14, 2013 (initiated Jan 14, 2013) |
| Status | Terminated |
| Reason | VS2+ screen may lock up and stop monitoring during patient use |
| Root cause | 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 Phi |
| Quantity | 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, SINGAPOR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112652 | SURESIGNS VS2+ -SURESIGNS VSI Philips Medical Systems, Oct 11, 2011 |