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05-09-2013, 11:50 AM #1
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- Aug 2012
- Merced, CA 95348-1422
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Recall: HeartStart MRx Monitor/Defribillator
Product Description HeartStart MRx Monitor/Defribillator; Product
Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Recall Number Z-1189-2013
Classification Class II
Code Info Serial numbers ranging from US00100100 to US00565942 Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6
Product Distributed Qty 64972
Reason For Recall Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.
Event Id 64860
Product Type Devices
Recalling Firm Philips Healthcare Inc., Andover, MA, USA
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: USA (nationwide) and countries of: Afghanistan, Albania, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegowina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kuwait, Laos, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Malta, Mexico, Mongolia, Morocco, Namibia, Nepal, Netherlands (Antilles), New Caledonia, New Zealand, Nicaragua, Nigera, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, 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), Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Veit Nam, and Yemen.