Z-1780-2013Class II

Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part Number...

Name: Z-1780-2013 Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part Number...
Creator: Philips Healthcare Inc.
Published: 2013-07-08
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-07-08 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of 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... on 2013-07-08. FDA classified it as Class II and gives the reason as "IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1780-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-08
Posted: 2013-07-20
Terminated: 2017-05-17
Recalling firm: Philips North America LLC
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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity
Root cause tag: software
FDA root cause: 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
Product codes and lots: Serial numbers ranging from: US12700465 to US20823366

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1780-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1780-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-19

Product code MHX

K041741Class IIM3290a Intellivue Information Center Software Release F.0 and M4840a Philips Telemetry System II Including M4841a PatienPhilips Medical Systems, Inc. / cleared 2004-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)