Philips Intellivue Patient Monitor Model MP60 (M8005A)
This recall has been terminated (originally issued August 10, 2010).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- June 28, 2010
- Posted
- August 10, 2010
- Terminated
- February 15, 2017
- Recall Number
- Z-2201-2010
- Quantity
- 11,529 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Additional Instruction for Use for Intellivue MP60/MP70 to prevent monitors from becoming loose and detaching from the mounting arm.
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.
Lot / Code Info
Serial Numbers: DE22701289 - DE843 16576
Root Cause
Labeling design
Action Taken
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.