Source

SFDA- Saudi Food & Drug Authority.

https://ade.sfda.gov.sa/Fsca/PublishDetails/232

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

1. Please follow "Actions Required" in the attachment.

2. If ALL device serial numbers match, no further action is required.

3. If you wish to continue to use your affected devices in the interim before Space labs service representative can be corrected the "Temporary workaround for affected devices" in the attachment can be used.

4. Contact the local agent for remedial action.

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