Recall Z-0817-2009 ยท DSI Detector And Alarm, Arrhythmia
Philips Medical Systems
Philips M8000-64100 Table Mount Shipped standard with all IntelliVue Patient Monitors MP40-70, Gas Modules Gl and G5 and certain options of the IntelliVue Patient Monitors MP5 MPST and MP20/30. Product shipped between 6/03/08 and 9/12/08 as follows: M1013A IntelliVue G1 Gas Module M1019A IntelliVue GS Gas Module M8001A option E22 Quick release mount for IntelliVue MP20 M8002A option E22 Quick r
| Date | Jan 13, 2009 (initiated Oct 22, 2008) |
| Status | Terminated |
| Reason | Table Mounts assembled with incorrect length hardware may fall |
| Root cause | Process control |
| Action | Philips issued an "Urgent Medical Device Correction" notification to all potentially affected customers on 10/22/08 via UPS for the US customers. The letter mailed to customers outside the US by Philips' regulatory contacts in each country via a tracked method. The letter informs customers of the problem and gives instructions on how to identify affected table mounts. Field Service Engineers will be dispatched to each customer site to inspect each Table Mount. If customers detect any sign of a loose connection between the monitor and the mounting plate while they are awaiting the Field Ser |
| Quantity | 14,292 units |
| Distribution | Nationwide Canada Foreign: Argentina, Aruba, Australia, Austria, Bahain, Bangladesh, Belgium, Bosnia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Egypt, Finland, France, Gabon, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Iraq, Ireland , Italy, Japan, Korea, Liby |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082633 | INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Oct 3, 2008 |