| Date Initiated by Firm |
March 06, 2017 |
| Create Date |
April 04, 2017 |
| Recall Status1 |
Terminated 3 on May 25, 2018 |
| Recall Number |
Z-1707-2017 |
| Recall Event ID |
76656 |
| 510(K)Number |
K113125
|
| Product Classification |
Detector and alarm, arrhythmia - Product Code DSI
|
| Product |
Philips IntelliVue MX4O WLAN Patient Wearable Monitor
Product: 865352
Exchange part (service numbers):
453564615311 TELE PWM,802.lla/b/g,ECG only, US only
453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only
Product Usage:
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX4O is connected the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX4O does not automatically provide local monitoring or alarming when connected to the Information Center.
|
| Code Information |
The following product number and Exchange part numbers containing the combination of HW Revision C.01 .01 with SW Revisions B.05 or B.06 of the Philips IntelliVue MX4O Patient Wearable Monitor |
Recalling Firm/
Manufacturer |
Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
|
| For Additional Information Contact |
978-659-3000
|
Manufacturer Reason
for Recall |
Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to
Monitor Mode with audible alarms when association with central monitoring system is unsuccessful [incomplete]
|
FDA Determined
Cause 2 |
Software design |
| Action |
Philips issued Field Safety Notice on 3/6/17. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer .Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice:
When a No Data Tele INOP alert is displayed on a Philips IntelliVue Information Center iX ( PIIC iX ), check the MX40 as directed in the PIIC iX B.01 IFU, page 87. If the MX40 is in the Coverage Area, remove the battery, and reinsert the battery. If the MX40 is not in the Coverage Area, place the sector in the PIIC iX in standby as directed in the MX40 B.06 IFU, page 53, or return the patient and MX40 to the Coverage Area.
Philips is releasing a software upgrade B.06.18 for affected Philips IntelliVue MX40 Patient Wearable Monitors.
A Philips Healthcare representative will contact customers with affected devices to arrange for the installation of the software upgrade |
| Quantity in Commerce |
2648 |
| Distribution |
Worldwide Distribution - US Nationwide including the countries of:
Australia
Belgium
Canada
Denmark
Finland
France
Germany
Germany
India
Italy
Netherlands
Norway
Qatar
Singapore
South Africa
Sweden
Switzerland
United Kingdom |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = DSI and Original Applicant = PHILIPS MEDICAL SYSTEMS
|
