IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865
FDA device recall Z-1746-2014 · posted 2014-06-10 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.
- Action taken
- On May 22, 2014, each affected customer was sent an Urgent Medical Device Correction notification/Field Safety Notice. The letter explains the problem, explains the action to be taken by the consumer, and the action planned by Philips. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of a free of charge software upgrade. A Philips Healthcare representative will contact customers with affected devices to arrange for service. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: The following two items must be configured when using MX40 with the IntelliVue Information Center iX: 1. Utilize the default state of Pause Alarms at Yellow only, which disables the ability to Pause/Suspend all Red level alarms Utilize the default state of Remote Suspend Alarms as Off, which disables the use of the Pause Alarms feature at the MX40 device
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 42,600
- Distribution
- United States: Nationwide Foreign Countries: Germany, Austria, Finland, Sweden, Australia, Qatar, Canada, Netherlands, New Zealand, Portugal, United Kingdom, Spain, Belgium, France, Switzerland, Norwa
- Date initiated
- 2014-05-22
- Date posted
- 2014-06-10
- Date terminated
- 2018-05-16
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTELLIVUE MX40 PATIENT MONITOR (K113125) | Philips Medical Systems | 2011-11-17 |
| INTELLIVUE MX40 PATIENT MONITOR (K103646) | Phillips Medical Systems | 2011-01-07 |