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U.S. Department of Health and Human Services

Class 2 Device Recall Luminos Agile Max

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 Class 2 Device Recall Luminos Agile Maxsee related information
Date Initiated by FirmNovember 23, 2022
Date PostedMay 23, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1479-2023
Recall Event ID 92229
510(K)NumberK173639 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductLuminos Agile Max (VE10, VF10, VF11)
Code Information Model: 10762472
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactRebecca Tudor
610-219-4834
Manufacturer Reason
for Recall		Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionSiemens Medical Solutions USA, Inc., will provide software updates to the affected systems with software versions VF10 and VF11 with software via Update Instructions (UI) XP007/23/S, XP004/23/S, XP003/23/S, and XP001/23/S
Quantity in Commerce704 units in the United States (1945 units worldwide)
DistributionUS Nationwide - Worldwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OWB
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