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Recall Observatory FDA recall evidence

Device 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.

Z-1780-2013

July 08, 2013

Class II

Product summary

Firm
Philips Healthcare Inc.
Event
Event 65622
Status
Terminated
Classification
Class II
Quantity
20105 units
Official record key
device-enforcement:Z-1780-2013

Official wording

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

Code information: Serial numbers ranging from: US12700465 to US20823366

Distribution pattern: USA Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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