Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
- Company
- Spacelabs Healthcare, Inc.
- Recall Initiated
- September 3, 2015
- Posted
- October 30, 2015
- Terminated
- September 7, 2016
- Recall Number
- Z-0172-2016
- Quantity
- 275 devices (20 in US and 255 international) and 113 PCBAs (international only)
- Firm Location
- Snoqualmie, WA
Reason for Recall
When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. The device has a self-test failure and will not operate normally.
Distribution
Worldwide Distribution - US Distribution in the states of Nebraska, South Carolina, and Washington and in the following countries of AUSTRALIA, BELGIUM, BOLIVIA, CANADA, CHILE, DENMARK, GERMANY, GUATEMALA, HONG KONG, ITALY, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, QATAR, SINGAPORE, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Lot / Code Info
PCBAs PN #: 670-1670-00. SERIAL NUMBERS in the US: CARD-200990, CARD-201287, CARD-623478, CARD-623775, CARD-624198, CARD-624224, CARD-624314, CARD-624387, CARD-624404, CARD-624413, CARD-624891, CARD-625061, CARD-625089, CARD-625124, CARD-625232, CARD-625269, CARD-625296, CARD-625304, CARD-625322, and CARD-625421. SERIAL NUMBERS OUTSIDE THE US: CARD-000019, CARD-000028, CARD-000037, CARD-000046, CARD-000064, CARD-000073, CARD-000073, CARD-000082, CARD-000091, CARD-000109, CARD-000118, CARD-000127, CARD-000136, CARD-000145, CARD-000163, CARD-000172, CARD-000181, CARD-000190, CARD-000208, CARD-000217, CARD-000226, CARD-000235, CARD-000244, CARD-000271, CARD-000280, CARD-000299, CARD-000307, CARD-000325, CARD-000334, CARD-000343, CARD-000352, CARD-000361, CARD-000370, CARD-000398, CARD-000406, CARD-000415, CARD-000424, CARD-000433, CARD-000442, CARD-000451, CARD-000479, CARD-000479, CARD-000488, CARD-000497, CARD-000505, CARD-000514, CARD-000523, CARD-000532, CARD-000550, CARD-000578, CARD-000596, CARD-000604, CARD-000613, CARD-000622, CARD-000631, CARD-000640, CARD-000659, CARD-000668, CARD-000677, CARD-000686, CARD-000703, CARD-000721, CARD-000730, CARD-000749, CARD-000758, CARD-000767, CARD-000776, CARD-000785, CARD-000785, CARD-000794, CARD-000802, CARD-000811, CARD-000820, CARD-000820, CARD-000839, CARD-000848, CARD-000857, CARD-000866, CARD-000875, CARD-000893, CARD-000910, CARD-000910, CARD-000929, CARD-000938, CARD-000947, CARD-000956, CARD-000974, CARD-000983, CARD-000992, CARD-001009, CARD-001018, CARD-001027, CARD-001027, CARD-001036, CARD-001045, CARD-001054, CARD-001063, CARD-001072, CARD-001072, CARD-001081, CARD-001090, CARD-001108, CARD-001117, CARD-001135, CARD-001144, CARD-001153, CARD-001171, CARD-001180, CARD-001199, CARD-001199, CARD-001207, CARD-001216, CARD-001225, CARD-001234, CARD-001243, CARD-001252, CARD-001261, CARD-001270, CARD-001289, CARD-001298, CARD-001306, CARD-001315, CARD-001333, CARD-001379, CARD-001388, CARD-001397, CARD-001405, CARD-001414, CARD-001423, CARD-001441, CARD-001603, CARD-002602, CARD-003304, CARD-003601, CARD-003908, CARD-005203, CARD-006103, CARD-200035, CARD-200116, CARD-200125, CARD-200486, CARD-200963, CARD-201016, CARD-201052, CARD-201124, CARD-201133, CARD-300016, CARD-300025, CARD-300034, CARD-300052, CARD-300070, CARD-300089, CARD-300098, CARD-300160, CARD-300188, CARD-300197, CARD-300205, CARD-300214, CARD-300223, CARD-300232, CARD-300269, CARD-300278, CARD-300313, CARD-300322, CARD-300331, CARD-300368, CARD-300395, CARD-300412, CARD-300421, CARD-300430, CARD-300458, CARD-300467, CARD-300476, CARD-300494, CARD-300511, CARD-300539, CARD-300548, CARD-300566, CARD-300576, CARD-300647, CARD-300656, CARD-300674, CARD-300692, CARD-300728, CARD-300755, CARD-300773, CARD-300782, CARD-300809, CARD-300818, CARD-300836, CARD-300881, CARD-300890, CARD-300917, CARD-300926, CARD-300944, CARD-301006, CARD-301042, CARD-301079, CARD-301114, CARD-301150, CARD-301178, CARD-301439, CARD-301484, CARD-400213, CARD-621894, CARD-623973, CARD-624846, CARD-625043, CARD-625160, CARD-625188, CARD-625250, CARD-625476, CARD-625511, CARD-625665, CARD-625818, CARD-627023, CARD-627546, CARD-627555, CARD-627564, CARD-627636, CARD-627645, CARD-627654, CARD-627663, CARD-627672, CARD-627708, CARD-627726, CARD-627744, CARD-627753, CARD-627771, CARD-627780, CARD-627834, CARD-627861, CARD-627898, CARD-627960, CARD-627997, CARD-628013, CARD-628031, CARD-628059, CARD-628077, CARD-628095, CARD-628112, CARD-628176, CARD-628220, CARD-628239, CARD-630065, CARD-630137, CARD-630146, CARD-630281, CARD-630443, CARD-630461, CARD-630498, CARD-630885, CARD-631235, CARD-631271, and CARD-631307.
Root Cause
Vendor change control
Action Taken
Spacelabs Healthcare sent an Urgent-Medical Device Correction letter, dated September 17, 2015 to US consignees (Hospital Administrator/Biomedical Manager/Office Manager). The firm plans to email a customer letter (translated as necessary) to international subsidiaries and distributors of record on 9/25/15. Customers were informed Spacelabs Healthcare will send a replacement CardioCall ECG Event Recorder(s) at no cost and a prepaid method to ease the return of the affected CardioCall device(s) back to Spacelabs. For additional information or technical assistance contact: Global Technical Support Spacelabs Healthcare, Ltd. 1 Harforde Court, John Tate Road Hertford SG13 7NW United Kingdom + 44 (0) 1992 507700 For USA Technical Support call 1-800-522-7025 and select 2 for Technical Support