Recall Z-0374-2016 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Medical Systems, Inc.
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alar
| Date | Dec 4, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification |
| Root cause | Software Design Change |
| Action | The firm, Philips Healthcare, issued a "URGENT-Field Safety Notice" on 12/19/14 to inform customers of the issue, identify details of the units affected, instructs on actions to be taken by the customer and identify what action Philips plans to take to remedy the issue. Philips will provide a software correction free of charge. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice-To prevent this issue from occurring, customers/users should: 1) Disable the Change Bed Label field in Patient Management. This is accomplished by changing |
| Quantity | 10,013 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries: AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CANADA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGARY, ICELAND, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, LUXEMBOURG, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, POLAND, PORTUGAL, QATAR, ROM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102495 | M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 Philips Medical Systems, Sep 30, 2010 |