—#125442

Product

HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K051134
Affected lot / code info: Model M3535A: US00100100 to US00541372 Model M3536A: US00100902 to US00541375 Model M3536J: US00209838 to US00332675 Model M3536MC: US00500001 to US00500020

Why it was recalled

A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to perform.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, Philips, sent an "URGENT - Medical Device Correction" letter dated February, 2014 with an attached Field Safety Notice to each known affected customer on 2/18/14. The letter describes the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The customers were instructed to continue to use your MRx prior to receiving the hardware upgrade; if a failure has been detected that may disable some ECG and SpO2 functionality during patient care, treat your patient per existing protocols and if the condition persists, take the device out of use and call for service from Philips authorized service personnel. Philips is initiating a correction to affected devices. A hardware upgrade will be provided free of charge for all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the hardware upgrade. If you have questions regarding this notification or need any further information or support, please contact your local Philips representative or call us at 1-800-722-9377.

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Worldwide Distribution: US (Nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and Internationally to: Canada, AFGHANISTAN, ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA (local name: Hrvatska), CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NETHERLANDS ANTILLES, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIET NAM, and YEMEN.

Timeline

Recall initiated: 2014-02-18
Posted by FDA: 2014-02-25
Terminated: 2017-01-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125442. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.