Devices

Spacelabs Healthcare CardioExpress SL6 ECG cable

Model / Serial
Serial numbers: 98400-SL6-AHA1030508, 98400-SL6-AHA1030509, 98400-SL6-AHA1030510, 98400-SL6-AHA1030511, 98400-SL6-AHA1030512, 98400-SL6-AHA1030513, 98400-SL6-AHA1030514, 98400-SL6-AHA1030515, 98400-SL6-AHA1030516, 98400-SL6-AHA1030517, 98400-SL6-AHA1030518, 98400-SL6-AHA1030519, 98400-SL6-AHA1030520, 98400-SL6-AHA1030521, 98400-SL6-AHA1030522.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution.
Product Description
Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. || The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.
Manufacturer
Del Mar Reynolds Medical, Ltd.
1 Event
- Recall of Spacelabs Healthcare CardioExpress SL6 ECG cable

Manufacturer

Del Mar Reynolds Medical, Ltd.

Manufacturer Address
Del Mar Reynolds Medical, Ltd., 1-2 Harforde Ct., Foxholes, Business Park, Hertford United Kingdom
Manufacturer Parent Company (2017)
OSI Systems Inc
Source
USFDA

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