Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Healthcare CardioCall ECG Event Recorder

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Spacelabs Healthcare CardioCall ECG Event Recorder see related information
Date Initiated by Firm September 03, 2015
Date Posted October 30, 2015
Recall Status1 Terminated 3 on September 07, 2016
Recall Number Z-0172-2016
Recall Event ID 72211
510(K)Number K972649  
Product Classification Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Spacelabs Healthcare Inc
35301 SE Center St
Snoqualmie WA 98065-9216
Manufacturer 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.
FDA Determined
Cause 2		 Vendor change control
Action 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
Quantity in Commerce 275 devices (20 in US and 255 international) and 113 PCBAs (international only)
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXH and Original Applicant = REYNOLDS MEDICAL LTD.
-
-