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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION OASIS XP 1.2T OPEN MRI SYSTEM MAGNETIC RESONANCE DIAGNOSTIC DEVICE

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FUJIFILM HEALTHCARE CORPORATION OASIS XP 1.2T OPEN MRI SYSTEM MAGNETIC RESONANCE DIAGNOSTIC DEVICE Back to Search Results
Model Number N/A
Device Problem Temperature Problem (3022)
Patient Problem Burning Sensation (2146)
Event Date 05/19/2022
Event Type  malfunction  
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Brand NameOASIS XP 1.2T OPEN MRI SYSTEM
Type of DeviceMAGNETIC RESONANCE DIAGNOSTIC DEVICE
Manufacturer (Section D)
FUJIFILM HEALTHCARE CORPORATION
2-1 shintoyofuta
kashiwa-shi, chiba-ken 277-0 804
JA 277-0804
Manufacturer (Section G)
FUJIFILM HEALTHCARE CORPORATION
2-1 shintoyofuta
kashiwa-shi, chiba-ken 277-0 804
JA 277-0804
Manufacturer Contact
katsuyuki minagawa
2-1 shintoyofuta
kashiwa-shi, chiba-ken 277-0-804
JA   277-0804
MDR Report Key14713750
Report Number3018423337-2022-00007
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 06/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/27/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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