FDA-Device2025-09-17Class II
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Boston Scientific Corporation
Hazard
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Sold states
Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
Affected count
1 unit
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2551-2025Don't want to check this manually?
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