Z-0105-2015Class II

Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A...

Name: Z-0105-2015 Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A...
Creator: Philips Medical Systems, Inc.
Published: 2014-10-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-10-03 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological... on 2014-10-03. FDA classified it as Class II and gives the reason as "Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped". 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-0105-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-03
Posted: 2014-10-21
Terminated: 2017-01-31
Recalling firm: Philips North America LLC
Product: Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.
Product code: HGM System, Monitoring, Perinatal
Reason for recall: Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
Root cause tag: software
FDA root cause: Software Design Change
Action: Philips Healthcare issued on 10/3/14 the Urgent Medical Device Correction notification/Field Safety Notice. The letter informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of a software upgrade free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for service. 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: During the interim period until the SW is upgraded please make sure, if the NBP repetition interval needs to be increased (e.g. from 5 to 15 minutes), to restart the automatic NBP measurement. Please review this information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication.
Quantity in commerce: 118 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA AUSTRIA BAHRAIN BELGIUM CHINA COLOMBIA CZECH REPUBLIC DENMARK FINLAND FRANCE GERMANY HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN KAZAKHSTAN NETHERLANDS NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN POLAND ROMANIA RUSSIA SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE and UNITED KINGDOM.
Product codes and lots: software revision J.30.58:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0105-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0104-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-21
Z-0105-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-21

Product code HGM

K111083Class IIPhilips Avalon Fetal/maternal Monitors Fm20, Fm30, Fm40 and Fm50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN / cleared 2011-08-17

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)