Recall Z-0373-2010 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Healthcare Inc.
SureSigns Vital Signs Monitors (VS3)-Vital Signs Viewer Central Viewing Station View up to 12 VM monitors at 1 time Part number: 863069,863070,863071,863072,863073,863074,453564041251,453564041261, 453564041271,453564041281,453564041291, 453564041301 The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, p
| Date | Nov 23, 2009 (initiated Oct 30, 2009) |
| Status | Terminated |
| Reason | Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker |
| Root cause | Software design |
| Action | Customer notifications dated October 2009, in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. Customers will be instructed to lower the volume setting while using existing units during the first notification. As part of the second notification to the customers, the field action correction will be a customer installable software upgrade. Customers may contact Philips Response Center with questions or concerns at 1.800.722.9377. On December 14, the firm issued the follow-up notificati |
| Quantity | 18,594 units |
| Distribution | Nationwide Foreign: Canada Afghanistan, Albania, Algeria, Angola, Argentina, Austria, Australia, Bahrain, Bosnia & Herzegowina, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Cyprus, Czech Republic, Germany, Denmark, Domi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070588 | PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER) Philips Medical Systems, Mar 20, 2007 |