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Terminated

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.

FDA Recall Z-1780-2013 · Posted 2013-07-20

Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeMHX
Date Initiated2013-07-08
Date Terminated2017-05-17
Product Quantity20105 units

Reason for Recall

IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity

Firm 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

Root Cause

Software Design Change

Distribution Pattern

USA Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041741M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIENPhilips Medical Systems, Inc. · 2004-07-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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