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U.S. Department of Health and Human Services

Class 2 Device Recall Functional MR V1.0

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  Class 2 Device Recall Functional MR V1.0 see related information
Date Initiated by Firm August 10, 2023
Date Posted October 18, 2023
Recall Status1 Open3, Classified
Recall Number Z-0122-2024
Recall Event ID 93049
510(K)Number K221426  
Product Classification System, image processing, radiological - Product Code LLZ
Product Functional MR V1.0
Code Information UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3
Recalling Firm/
Manufacturer		 OLEA MEDICAL
93 AVANUE DU SORBIER,
ZONE ATHELIA IV
LA CIOTAT France
Manufacturer Reason
for Recall		 When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to a misinterpretation of clinical data.
FDA Determined
Cause 2		 Software design
Action On 8/10/23, field safety notices were emailed to customers who were told to take the following actions: Advice for the user to detect if the bug occurred: This defect can be detected within the Functional MR V1.0 user interface by displaying the exported volume on an anatomical sequence. To detect the issue, the VOI shall be dragged and dropped from the data browser on an anatomical sequence, which will display a notification, indicating the original VOI s name. Outside of Functional MR V1.0 user interface, the user may check the DICOM tag "Segment Label (0062,0003)" in the viewer used, as this DICOM tag contains the correct VOI s name. Workaround: This problem can be overcome when exporting VOIs individually and has no impact on exporting VOIs merged with an anatomical map. New software will be available in October 2023. Complete and return the reply form via email to qa-ra@olea-medical.com
Quantity in Commerce 2
Distribution US: MI, MA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = Olea Medical SAS
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