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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare IntelliVue Smarthopping 1.4 GHz Access Point

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  Class 2 Device Recall Philips Healthcare IntelliVue Smarthopping 1.4 GHz Access Point see related information
Date Initiated by Firm July 08, 2013
Date Posted July 20, 2013
Recall Status1 Terminated 3 on May 17, 2017
Recall Number Z-1780-2013
Recall Event ID 65622
510(K)Number K041741  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Radiohead Access Point 1.4 GHz Radiohead Access Point
Firmware versions: C.00.04 & C.00.05
Part Number: 989803171211

Product Usage:
IntelliVue Smart-hopping 1.4 GHz Access Point provides wireless connectivity between IntelliVue devices (listed below) and the Philips IntelliVue Information Center. MX40 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.
Code Information Serial numbers ranging from: US12700465 to US20823366
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		 IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity
FDA Determined
Cause 2		 Software Design Change
Action Philips sent an Urgent Medical Device Correction letter dated July 2013 to affected customers. The letter informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer. Philips will perform a firmware upgrade (version C.00..07 for all affected customers at no cost. 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. If you need any further information or support concerning this issue, please contact Philips Customer Support at 1-800-722-9377
Quantity in Commerce 20105 units
Distribution USA Nationwide Distribution
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 = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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