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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 60480

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 27, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Terumo Cardiovascular Systems Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

Z-1730-2013
Recall number
Z-1730-2013
Initiated
February 27, 2013
Classification
Class II
Status
Terminated
Quantity
3972 units since 4/26/12

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software update has been developed to address this issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the

Code information

Catalog number: 500AVHCT* and serial numbers: 0012, 1001-1022, 1024, 1028, 1032, 1033,1036, 1038, 1039, 1041-1044, 1046, 1047,1049-1053,1059,1063,1066-1071,1075,1096,1097,1101-1105, 1111-1304-1309,1312-1315,1321,1332-1334,13401344,1350-1354, 1357, 1358, 1379-1383, 13891393,1399-1408,1414-1418, 1421, 1422, 14241433, 1439-1443, 1449-1453, 1459-1463, 1466,1479, 1480, 1494, 1525, 1554, 1597-1601,1605,1617-1631,1637-1646,1657-1661,16721676,1682-1686,1697-1701,1712-1716, 1733-1737, 1787-1789, 1805-1809, 1815-1819, 1830, 1844-1846, 1857-1860, 1886-1890, 1901-1905,1916-1920, 1926-1930, 1936-1940, 1953-1974,1976-1985, 2029-2034, 2036-2038, 2040, 2045, 2059-2063, 2065-2067, 2070-2077, 2086, 2097-2101, 2109-2111, 2113-2115, 2123-2131, 2138-2142, 2149-2155, 2177-2182, 2185-2187, 2189,2195-2199, 2214, 2216-2219, 2224, 2228-2231, 2243-2245, 2249-2253, 2255-2258, 2260, 2263, 2265-2268, 2275-2277, 2279, 2285-2291, 22952298, 2313-2321, 2323-2329, 2338-2354, 2357, 2366,2368-2375,2377,2392,2403-2408,24172426, 2432-2436, 2439-2444, 2453-2458, 2463-2467, 2470-2472, 2476-2483, 2487-2503, 2514-2517,2521-2525,2541-2556,2565-2582,2587-2603, 2629-2633, 2635-2642, 2646, 2647, 2656, 2661,2662,2664-2680,2689-2691,2695,2696, 2701-2708, 2710-2716, 2722-2727, 2737, 2742-2747, 2757-2773, 2783, 2784, 2788, 2793-2795, 2802,2805-2808,2815-2820,2837-2839,28462849, 2865-2870, 2880-2889, 2892-2895, 2906-2908,2913- 2915,2920,2921,2924-2926, 2937-2940, 2942-2947, 2952, 2958-2975, 2979-2983, 2990-2999, 3008-3010, 3022-3027, 3040, 3041, 3052-3055, 3073-3075, 3083-3087, 3096, 3115, 3116, 3139-3145, 3152, 3153, 3155-3162, 3169-3182, 3190-3196, 3214-3220, 3225-3228, 3232, 3238-3245, 3248, 3249, 3264-3268, 3287, 3288, 3291-3306, 3314-3323, 3329-3334, 3340-3349, 3354-3357, 3369-3373, 3383-3391, 3394-3397, 3402-3406, 3416, 3418-3427, 3434-3437, 34413447, 3449-3456, 3458-3462, 3469-3472, 3481, 3482, 3489, 3490, 3500-3503, 3509, 3510, 3518, 3534, 3535, 3541-3545, 3571-3573, 35903609, 3612-3619, 3624-3628, 3636-3639, 36433645, 3669-3681, 3698-3703, 3715, 3716, 3722-3726, 3738-3744, 3753-3757, 3769-3780, 3784-3787, 3799-3804, 3811-3816, 3827-3830, 3838-3841, 3852-3881, 3892-3899, 3902-3906, 3912-3921, 3924-3931, 3937-3952, 3962-3965, 3971-3974, 3986-3989, 3995-3998, 4006-4029, 4038-1113, 1115, 1130, 1133-1140,1146-1152, 1166-1168, 1181-1185, 1216-1220,1231-1236, 1244-1248,1254,1255,1261-1264, 1270-1274, 1285, 1286-1289, 1295-1299, 4043, 4050-4055, 4070-4075, 4082-4089, 4096-4099,4105-4108,4114-4131,4143-4148,4169-4185, 4203-4212, 4219-4224, 4230-4241, 4260-4280, 4290-4299, 4307-4310, 4318-4323, 4335-4344,4351,4352,5001-5010,5036-5039,5048- 5056, 5065-5077, 5082-5085, 5094-5101, 5118-5125,5142-5149,5158-5169, 5178, 5179, 5190, 5197,5198, 5210-5213,5222-5225,5238-5245, 5250-5253, 5274-5277, 5282-5285, 5290-5293, 5298-5305,5318-5321,5334-5337,5341-5344, 5354-5356, 5370-5374, 5383, 5385, 5386, 5516-5526,5532-5541, 5557-5561, 5584-5592, 5601-5608, and 7992.

Distribution pattern

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, 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, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.

device · product 2 of 5

CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

Z-1731-2013
Recall number
Z-1731-2013
Initiated
February 27, 2013
Classification
Class II
Status
Terminated
Quantity
3972 unit since 4/26/12

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software update has been developed to address this issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the

Code information

Catalog number: 500AHCT* and serial numbers: 1023,1025-1027,1029-1031, 1034,1035,1037,1040, 1045, 1048, 1054-1058, 1060-1062, 1064, 1065, 1072-1074, 1076-1095,1098-1100,1106-1110,1114,1116-1129,1131,1132,1141-1145, 1153-1165,1169-1180,1186-1191,1194-1210, 1212-1215,1221, 1230, 1237-1243,1249-1253,1256-1260,1265-1269,1275-1284,1290-1294,1300-1303, 1310, 1311, 1316-1320, 1322-1331,1335-1339,1345-1349,1359, 1378,1384-1388, 1394-1398,1409-1413,1419,1434-1438,1444-1448, 1454-1458, 1469-1478, 1481, 1482, 1484-1493,1495-1503,1505-1520,1528,1531-1553, 1555-1558,1567-1596,1607-1616,1632-1636,1647-1656,1667-1671,1677-1681,1687-1696, 1702-1711,1717-1721,1728-1732,1738-1753, 1759-1775,1777-1786,1790-1794,1796-1804,1810-1814,1820-1829,1831-1843,1847-1850, 1856, 1861-1885, 1891-1900, 1906-1915,1921-1925,1931-1935,1941-1950,1975,1986-2015, 2017-2022, 2024-2028, 2039, 2041-2044, 2046-2058, 2064, 2068, 2069, 2078-2085, 2087-2096, 2108, 2116, 2118- 2122, 2132-2137, 2143-2148, 2156-2176, 2183, 2184, 2188, 2191-2194, 2200-2213, 2215, 2220-2223, 2225-2227, 2232-2242, 2247, 2248, 2254, 2259,2261, 2262, 2264, 2269-2272, 2278, 2280-2284, 2292-2294, 2299-2312,2330-2337, 2353, 2359-2363, 2376, 2378-2388, 2398-2402, 2409-2416, 2427-2431, 2437, 2438, 2445-2452, 2459-2462, 2468, 2469, 2473-2475, 2484-2486, 2505-2513, 2518-2520, 2526-2540, 2557-2564, 2583-2586, 2604-2628, 2643-2645, 2648-2655, 2657-2660, 2663, 2684-2688,2692-2694,2697-2699, 2709, 2717-2721, 2728-2736, 2738-2741, 2748-2756, 2774-2782, 2785-2787, 2789-2792, 2796-2799, 2803, 2809-2814,2821-2836,2840-2845,2850-2859,2861-2864, 2871-2879, 2896-2900, 2903-2905, 2909-2912, 2916-2919, 2922, 2923, 2927-2936, 2941, 2948-2951, 2953-2957, 2976-2978, 2984-2989, 3000-3007, 3014-3021, 3028-3039, 3042-3051, 3056-3072, 3076-3082, 3088-3095, 3097-3114, 3117-3124,3126-3130,3136-3138,3147-3151, 3154,3163-3168,3183-3189, 3197-3213,3221-3224,3229-3231,3233-3237,3246,3247,3250-3260, 3269-3286,3290,3307-3313,3324-3328, 3335-3339, 3350-3353, 3358-3368, 3374-3382, 3392, 3393, 3398-3401, 3407-3409, 3411-3415, 3428-3433, 3438-3440, 3448, 3457, 3463-3468, 3473-3479,3483-3488,3491-3499,3504-3508, 3511-3517,3519-3533,3536-3540,3546-3570, 3574-3589,3610,3611,3620-3623,3632-3635, 3640-3642,3649-3660, 3662-3668,3682-3697, 3704-3714, 3717-3721,3727-3737,3745-3752, 3758-3768, 3781-3783, 3788-3798, 3805-3810, 3817-3826,3831-3837,3842-3851,3882-3891, 3900,3901,3907-3911,3922,3923,3932-3936, 3953-3961, 3966-3970, 3975-3985, 3990-3994, 3999-4005,4030-4037,4044-4049,4056-4069, 4076-4081, 4090-4095, 4100-4104, 4109-4113, 4133-4142,4149-4168,4186-4202,4213-4218, 4225-4229, 4242-4259,4281-4289,4300-4306, 4311-4317, 4324-4334, 4345-4350, 4353-4371, 5011-5035, 5040-5047, 5057-5064, 5078-5081, 5086-5093, 5102-5117, 5126-5141, 5150-5157, 5170-5177, 5180-5189, 5191-5196, 5199-5209, 5214-5221, 5226-5237, 5246-5249, 5254-5273, 5278-5281, 5286-5289, 5294-5297, 5306-5317, 5322-5329, 5345-5348, 5350-5353,5358-5369, 5375-5382, 5387, 5388, 5500-5515, 5527-5531, 5542-5556,5562-5564,5566-5577,5581-5583, 5593-5600, 5609-5660, 5662-5680, 5682-5688, 5690-5706, 5708-5713, 5715-5722, 5725-5727,and 5731.

Distribution pattern

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, 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, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.

device · product 3 of 5

CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

Z-1732-2013
Recall number
Z-1732-2013
Initiated
February 27, 2013
Classification
Class II
Status
Terminated
Quantity
3972 since 4/26/12

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.

Code information

Catalog number: 500AV* and serial numbers: 0024, 0033, 0040, 0051, 1192, 1193, 1355,1356, 1420, 1423, 1464, 1465, 1467, 1468,1483,1504,1521-1524,1526,1527,1529,1530, 1602-1604, 1606, 1662, 2023, 2035, 2102-2107, 2800, 2901,2902, 3131-3135, 3261, 3262, 4132, 5330-5333, 5338-5340, 5578, and 5579.

Distribution pattern

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, 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, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.

device · product 4 of 5

CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

Z-1733-2013
Recall number
Z-1733-2013
Initiated
February 27, 2013
Classification
Class II
Status
Terminated
Quantity
3972 units since 4/26/12

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software update has been developed to address this issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the

Code information

Catalog number: 500A* and serial numbers: 1211,1559-1563,1663-1666,1722-1727,1754-1758, 1776, 1795, 1951, 1952, 2016, 2112, 2117, 2190, 2246, 2273, 2274, 2322, 2355, 2356,2389-2391, 2393, 2394, 2397, 2634, 2700, 2801, 2804, 2860, 2890, 2891, 3011-3013, 3125, 3146, 3263, 3289, 3410, 3417, 3480, 3629-3631, 3646-3648, 3661, and 5349.

Distribution pattern

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, 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, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.

device · product 5 of 5

CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

Z-1734-2013
Recall number
Z-1734-2013
Initiated
February 27, 2013
Classification
Class II
Status
Terminated
Quantity
3972 units since 4/26/12

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software update has been developed to address this issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the

Code information

Catalog number: 500V* and serial numbers: 1564-1566

Distribution pattern

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, 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, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.