Recall Z-0172-2016— Spacelabs Healthcare Inc

Name: FDA recall Z-0172-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-03

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2015-09-03, terminated 2016-09-07. It names one FDA 510(k) clearance: K972649. 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.. 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..

Recalling firm: Spacelabs Healthcare Inc
Classification: Class II
Status: Terminated
Initiated: 2015-09-03
Terminated: 2016-09-07
Firm location: Snoqualmie, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K972649 — CARDIOCALL CARDIAC EVENT RECORDERReynolds Medical , Ltd.·cleared 1997-12-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.