Z-2201-2010

Philips Intellivue Patient Monitor Model MP60 (M8005A)

Name: Z-2201-2010 Philips Intellivue Patient Monitor Model MP60 (M8005A)
Creator: Philips Healthcare Inc.
Published: 2010-06-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-06-28 / Terminated / root cause: labeling and UDI

FDA source

Philips Healthcare Inc. began a recall of Philips Intellivue Patient Monitor Model MP60 (M8005A) on 2010-06-28. The reason FDA records is "Additional Instruction for Use for Intellivue MP60/MP70 to prevent monitors from becoming loose and detaching from the mounting arm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2201-2010
Status: Terminated
Initiated: 2010-06-28
Posted: 2010-08-10
Terminated: 2017-02-15
Recalling firm: Philips North America LLC
Product: Philips Intellivue Patient Monitor Model MP60 (M8005A)
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Additional Instruction for Use for Intellivue MP60/MP70 to prevent monitors from becoming loose and detaching from the mounting arm.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Philips issued on 6/28/10 an Urgent Medical Device Correction notification/Field Safety Notice. Included with the Urgent Medical Device Correction notification/Field Safety Notice is an updated instructions for use and service instructions for these monitors that remind users to follow the mounting arm manufacturer's instructions for use when repositioning the monitor and instructing them to perform a periodic check that the monitor is not loose on the arm.
Quantity in commerce: 11,529 units
Distribution: Worldwide distribution: USA, Canada, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, Bosnia, BRAZIL, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRI, LITHUANIA, LUXEMBOURG, MACAU, MALAYSIA, MAURITIUS, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA & MONTE NEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, United Arab Emirates, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, VIRGIN ISLANDS (BR), and YEMEN.
Product codes and lots: Serial Numbers: DE22701289 - DE843 16576

Product code MHX

K093268Class IIIntellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN / cleared 2010-05-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)