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.
Description du dispositif
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.
Units Affected: MRx unit types with software versions F.03.06 (M3535A) and T.00.05 (M3536A) and earlier and the following part numbers:
PMS Number: 861288
Part Number: M3535A
PMS Number: 989803132391
Part Number: M3535ATZ
PMS Number: 861289
Part Number: M3536A
PMS Number: 989803132401
Part Number: M3536ATZ
PMS Number: 861314
Part Number: M3536J
PMS Number: 861464
Part Number: M3536M
PMS Number: 861481
Part Number: M3536M2
PMS Number: 861483
Part Number: M3536M4
PMS Number: 861484
Part Number: M3536M5
PMS Number: 861491
Part Number: M3536M6
PMS Number: 861465
Part Number: M3536MC
Product: Philips HeartStart MRx Lithium Ion batteries
Model: M3538A
serial numbers: 11327-0019-P, 11315-0023-P, 11315-0027-P, 11315-0031-P, 11315-0032-P, 11315-0033-P, 11315-0036-P, 11315-0109-P, 11315-0214-P, 11315-0219-P, 11315-0391-P, 11322-0084-P, 11322-0088-P, 11327-0043-P, 11327-0044-P
Or within the following range:
11335-xxxx-P to 13214-xxxx-P