Recall Z-0172-2016 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
Spacelabs Healthcare Inc
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.
| Date | Oct 30, 2015 (initiated Sep 3, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 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, UNITE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972649 | CARDIOCALL CARDIAC EVENT RECORDER Reynolds Medical , Ltd., Dec 4, 1997 |