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Terminated

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.

FDA Recall Z-0172-2016 · Posted 2015-10-30

Recalling FirmSpacelabs Healthcare Inc
Recall StatusTerminated
Product CodeDXH
Date Initiated2015-09-03
Date Terminated2016-09-07
Product Quantity275 devices (20 in US and 255 international) and 113 PCBAs (international only)

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.

Firm 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

Root Cause

Vendor change control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972649CARDIOCALL CARDIAC EVENT RECORDERReynolds Medical , Ltd. · 1997-12-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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