FDA-Device2023-04-05Class II
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
Siemens Medical Solutions USA, Inc
Hazard
In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.
Sold states
US Nationwide distribution.
Affected count
141 units US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1311-2023Don't want to check this manually?
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