NRAC Issue #1612 ADDENDUM January 9, 2007 --------------------------------------------------------------------------- PRODUCT HeartStart FR2+ Defibrillator RECALL NUMBER # Z-0308-2007 CODE Serial Numbers affected: 1204137082, 1204137014, 1204137016, 1204137022, 1204137126, 1204137128, 1204137132, 1204137136, 1204137146, 1204137018, 1204137020, 1204137124, 1204137130, 1204137134, 1204137138, 1204137028, 1204137030, 1204137032, 1204137036, 1204137038, 1204137040, 1204137042, 1204137044, 1204137046, 1204137048, 1204137050, 1204137064, 1204137070, 1204137072, 1204137074, 1204137076, 1204137078, 1204137080, 1204137084, 1204137086, 1204137088, 1204137090, 1204137092, 1204137094, 1204137140, 1204137162, 1204137164, 1204137166, 1204137168, 1204137196, 1204137198, 1204137200, 1204137202, 1204137204, 1204137206, 1204137208, 1204137034, 1204137144, 1204137142, 1204137228, 1204137396, 1204137054, 1204137056, 1204137058, 1204137060, 1204137062, 1204137066, 1204137068, 1204137096, 1204137100, 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0305144184, 0305144216, 0305144164, 0305144527, 0305144531, 0305144533, 0305143575, 0305144288, 0305144290, 0305144294, 0305144292, 0305146032, 0205141151, 0405149787, 0405149801, 0405149813, 0405149826, 0405150654, 0405150658, 0405150686, 0505152536, 0505152919, 1005170558, 0106179348, 0106179344, 0406191022 MANUFACTURED & RECALLED BY Philips Medical Systems, Seattle, WA REASON Potential for shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation. QUANTITY 2,000 units DISTRIBUTION Nationwide and Internationally --------------------------------------------------------------------------- PRODUCT a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763 RECALL NUMBER # Z-0322-2007 PRODUCT b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764 (Not distributed within the United States) RECALL NUMBER # Z-0323-2007 PRODUCT c) Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040 RECALL NUMBER # Z-0324-2007 PRODUCT d) Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041 RECALL NUMBER # Z-0325-2007 PRODUCT e) Terumo Advanced Perfusion System 1 Air Bubble Detection Module; Catalog number 802110 RECALL NUMBER # Z-0326-2007 PRODUCT f) Terumo Advanced Perfusion System 1 Data Interface CDI 100; Catalog number 802558 RECALL NUMBER # Z-0327-2007 PRODUCT g) Terumo Advanced Perfusion System 1 Data Interface CDI 500; Catalog number 803479 RECALL NUMBER # Z-0328-2007 PRODUCT h) Terumo Advanced Perfusion System 1 Venous Occluder; Catalog number 803480 RECALL NUMBER # Z-0329-2007 PRODUCT i) Terumo Advanced Perfusion System 1 Level Detection; Catalog number 802111 RECALL NUMBER # Z-0330-2007 PRODUCT j) Terumo Advanced Perfusion System 1 Pressure Monitoring; Catalog number 802112 RECALL NUMBER # Z-0331-2007 PRODUCT k) Terumo Advanced Perfusion System 1 Temperature Monitoring System; Catalog number 802114 RECALL NUMBER # Z-0332-2007 PRODUCT l) Terumo Advanced Perfusion System 1 Flow Module; Catalog number 802018 RECALL NUMBER # Z-0333-2007 PRODUCT m) Terumo Advanced Perfusion System 1 Data Interface RS 485; Catalog number 803518 RECALL NUMBER # Z-0334-2007 PRODUCT n) Terumo Advanced Perfusion System 1 Control Unit; Catalog number 801046 RECALL NUMBER # Z-0335-2007 PRODUCT o) Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188 RECALL NUMBER # Z-0336-2007 PRODUCT p) Advanced Perfusion System 1 Central Control Monitor; Catalog number 802100 RECALL NUMBER # Z-0337-2007 CODE a) Serial numbers: 0013, 0017, 0019 through 0039, 1141 through 0163, 0165 through 0200 and 0203 through 0244 b) Serial numbers 0006 through 0066, 0100 through 0116, 0118 and 0119 c) Serial numbers: 0031, 0032, 0034 through 0041, 0045, 0047 through 0050, 0052, 0054, 0056 through 0059, 0064, 0067, 0071 through 0073, 0075 through 0080, 0082 through 0086, 0088 through 0095, 0097 through 0099, 0101 through 0105, 0107, 0108, 0110, 0111, 0113 through 0135, 0137 through 0140, 0142 through 0165, 0167 through 0180, 0182 through 0191, 0194, 0195, 0197 through 0204, 0206, 0207, 0209, 0211 through 0235, 0237 through 0250, 0252 through 0291, 0293 through 0437, 0440 through 0522, 0524 through 0527, 0700 through 0725, 0727, 0730 through 0858, 0860 through 0878, 0880, 0881, 0885 through 0903, 0906 through 0912, 0922 and 0924 d) Serial numbers: 0033, 0034, 0036, 0038, 0041 through 0043, 0045, 0047 through 0049, 0052, 0054, 0055, 0057, 0058, 0061, 0063, 0064, 0069, 0072, 0075 through 0096, 0098, 0099, 0102 through 0116, 0118, 0124, 0127 through 0136, 0138 through 0146, 0148 through 0151, 0153 through 0163, 0165 through 0170, 0172, 0173, 0175, 0179, 0181 through 0187, 0189 through 0200, 0202 through 0231, 0233 through 0240, 0242 through 0278, 0281 through 0302, 0304 through 0481, 0483 through 0587, 0700 through 0753, 0757, 0758, 0760 through 0769, 0771 through 0787, 0789 through 0793, 0795 through 0866, 0868 through 0898, 0900 through 0921, 0923 through 0978, 0980 through 1001, 1004 through 1015, 1017, 1019 and 1024 through 1027 e) Serial numbers: 00023 through 00026, 00034, 00041, 00051, 00060, 00063 through 00065, 00067 through 00069, 00071 through 00089, 00091 through 00139, 00141 through 00242, 00246 through 00280, 00282 through 00297, 00299 through 00323, 00325 through 00410 and 00419 f) Serial numbers: 00008 through 00011, 00013, 00020 through 00030, 00032 through 00034, 00036 through 00059 and 00061 through 00078 g) Serial numbers: 00009 through 00012, 00014 through 00017, 00019, 00023 through 00037, 00039 through 00049, 00051 through 00119, 00121, 00122 and 00124 through 00149 h) Serial numbers: 00012 through 00019, 00021, 00025, 00027 through 00031, 00033 through 00053, 00055 through 00066, 00068 through 00075, 00078 through 00139, 00141 through 00147, 00149 through 00157 and 00159 through 00213 i) Serial numbers: 00023, 00025 through 00027, 00055, 00061 through 00081, 00083 through 00099, 00101 through 00109, 00111 through 00183, 00185 through 00260, 00262 through 00269. 00271 through 00293, 00295 through 00307 and 00309 through 00357 j) Serial numbers: 00017 through 00032, 00036, 00043, 00045 through 00057, 00059 through 00062, 00065 through 00071, 00073 through 00079, 00081 through 00099, 00102 through 00122, 00125 through 000251, 00253 through 00292, 00296 through 00309, 00311 through 00349, 00352 through 00479, 00484 and 00489 k) Serial numbers: 00019 through 00034, 00036, 00037, 00046 through 00053, 00055 through 00069, 00073 through 00114, 00116 through 00128, 00131 through 00193, 00195 through 00203, 00205 through 00334, 00339 through 00355, 00357 through 00414, 00416 through 00431. 00434, 00435, 00439 through 00447, 00448 through 00466, 00468 through 00473, 00475 through 00477, 00479 through 00582, 00584 through 00590, 00592 through 00594 and 00606 l) Serial numbers: 00017, 00020, 00023 through 00026, 00029 through 00031, 00033, 00034, 00036 through 00048, 00051 through 00055, 00057 through 00078, 00080 through 00120, 00122 through 00134, 00136, 00138 through 00155, 00158 through 00169, 00171 through 00210, 00212 through 00243 and 00248 m) Serial numbers: 00007 through 00014, 00016 through 00024 and 00026 through 00031 n) Serial numbers: 0020 through 0025, 0030 through 0036, 0038 through 0040, 0042, 0044, 0045, 0047 through 0081, 0083, 0084, 0086 through 0102, 0106 through 0110, 0112 through 0130, 0132 through 0137, 0139 through 0147, 0149 through 0154, 0157 through 0166, 0169 through 0175 and 0177 through 0189 o) Serial numbers: 00010 through 00016, 00019, 00024 through 00027, 00030 through 00033, 00035, 00036, 00038 through 00040, 00042 through 00046, 00048 through 00050, 00052 through 00054, 00056 through 00059, 00061 through 00063, 00065, 00066, 00068, 00069, 00071 through 00073, 00075 through 00078, 00082, 00084, 00085, 00087, 00088, 00091, 00094, 00095, 00098 through 00103, 00105 through 00107, 00109 through 00111, 00113 through 00115, 00122, 00126 through 00129, 00133 through 00135, 00139, 00140, 00144, 00145, 00147, 00148, 00151, 00152, 00154 through 00157, 00163, 00167, 00168 through 00174, 00176 through 00182, 00184 through 00196, 00200, 00202 through 00206, 00210, 00211, 00213, 00214, 00216 through 00224, 00228 through 00231, 00237 through 00241, 00245 through 00250, 00300 through 00327 and 00330 p) Serial numbers: 0047, 0049, 0052, 0054, 0055, 0065, 0066, 0069, 0071, 0072, 0074, 0076 through 0088, 0090 through 0111, 0113 through 0131, 0133 through 0276, 0278 through 0288, 0291 through 0293, 0295 through 0301 and 0303 through 0350 MANUFACTURED & RECALLED BY Terumo Cardiovascular Systems Corp., Ann Arbor, MI QUANTITY 4,740 devices DISTRIBUTION Nationwide and Internationally REASON Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen. ---------------------------------------------------------------------------