Oman Ministry of Health Circular No. 9/2025
Field Safety Corrective Action of Eclipse Pro & Eclipse Mini from Spacelabs Healthcare
Source | SFDA- Saudi Food & Drug Authority. |
Product | Product Eclipse Pro & Eclipse Mini |
Manufacturer | Spacelabs Healthcare |
Local agent | Al Mazroui Medical & Chemical Supplies LLC |
The affected products | Eclipse Mini REF 98900. Eclipse PRO REF 98700. |
Reason | Some of the above-mentioned Holter devices may have mismatched serial numbers between the label and what is programmed in the devices. |
Action |
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Comments | Healthcare professionals are encouraged to report any adverse events Suspected to be comments associated with the above device or any other medical device to Department of Medical Device Control through the E-mail: vigilance-md-moh.gov.om |
Dr. Mohammed Hamdan Al Rubaie
Director General
To:
THE DIRECTOR GENERAL OF HEALTH SERVICES IN ALL GOVERNORATES



