—#107347

Product

Philips IntelliVue Patient Monitors: The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in health care facilities. The monitor is to be used by trained health care professionals. Physiological Monitoring, Patient Monitor , Arrhythmia detector and alarm (including ST -segment measurement and alarm.

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K110622
Affected lot / code info: Models with SW Revision H (up to and including H.15.36) are affected, upgraded between October 6, 2010 and January 23, 2012 MP20 (M8001A), MP30 (M8002A), MP40 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70 (M8007A), MP80 (M8008A), MP90 (M8010A), D80 (M8016A), MX600 (865242), MX700 (865241) MX800 (865240

Why it was recalled

Central station monitors may not alarm (either visual or audible) when an alarm is announced at the affected patient monitor

Root cause (FDA determination)

Software change control

Action the firm took

Philips Healthcare sent a Urgent Medical Device Correction letter dated February 7, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips has recently received reports that, under certain circumstances, alarms announced at the patient monitor are not announced (either visual or audible) at the central station. This issue affects the following IntelliVue patient monitor models with SW rev. H.xx.xx MP20 (M8001A), MP30 (M8002A), MP40 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70 (M8007A), MP80 (M8008A), MP90 (M8010A), Intelligent Display D80 (M8016A), MX600 (865242), MX700 (865241) and MX800 (865240) If this issue occurs, the primary alarm function at the bedside monitor is not affected. Philips is conducting this voluntary correction to upgrade software on affected devices. Please refer to the following pages, which provide instructions for actions to be taken. Follow the Action to be taken by Customer/User section of the instructions. This issue has been reported to the appropriate regulatory agencies. Ensuring that you have the highest quality medical devices, accessories and supporting documentation is our top priority. Your satisfaction with Philips products is very important to us. Review this information with all staff members who interface with the central station and need to be aware of the contents of this communication. The Product Number and Serial Number is contained on the devices product label, located on the front of the device. The SW revision can be accessed via the Revision Screen at the bedside monitor. charge.A Philips Healthcare representative will contact customers with affected devices contact Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this correction to arrange an upgrade of the Intellivue software.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide Distribution -- USA (nationwide) and the countries of ALBANIA, ANGOLA, ANTILLES, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BYELORUSSIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GABON, GERMANY, GHANA, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LEBANON, LIBYAN, ARAB, JAMAHIRI, LITHUANIA, LUXEMBOURG,MACAU, MALAYSIA, MOROCCO, MAURITIUS, MEXICO, MOROCCO, NAMIBIA, NEPAL, NETHERLANDS, ANTILLES, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PALESTINE, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB, EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIET NAM, YEMEN, ARAB REP and ZAMBIA

Timeline

Recall initiated: 2012-02-09
Posted by FDA: 2012-03-01
Terminated: 2017-02-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107347. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.