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U.S. Department of Health and Human Services

Class 2 Device Recall Philips IntelliVue Patient Monitors

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  Class 2 Device Recall Philips IntelliVue Patient Monitors see related information
Date Initiated by Firm February 09, 2012
Date Posted March 01, 2012
Recall Status1 Terminated 3 on February 15, 2017
Recall Number Z-1134-2012
Recall Event ID 61127
510(K)Number K110622  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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.
Code Information 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
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact SAME
978-687-1501
Manufacturer Reason
for Recall		 Central station monitors may not alarm (either visual or audible) when an alarm is announced at the affected patient monitor
FDA Determined
Cause 2		 Software change control
Action 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.
Quantity in Commerce 83,534 units
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
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