FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Philips Intellivue Patient Monitor Model MP60 (M8005A)
- Recall number
- Z-2201-2010
- Recalling firm
- Philips Healthcare Inc.
- Product
- Philips Intellivue Patient Monitor Model MP60 (M8005A)
- Status
- Terminated
- Initiated
- 2010-06-28
- Posted
- 2010-08-10
- Terminated
- 2017-02-15
- Reason
- Additional Instruction for Use for Intellivue MP60/MP70 to prevent monitors from becoming loose and detaching from the mounting arm.
- 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
- 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.
- Lot, serial or model codes
- Serial Numbers: DE22701289 - DE843 16576
- 510(k) numbers
- ["K093268"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28