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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIC icono

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 Class 2 Device Recall ARTIC iconosee related information
Date Initiated by FirmAugust 12, 2025
Date PostedSeptember 05, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2529-2025
Recall Event ID 97444
510(K)NumberK241572 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductArtis Pheno. Image-Intensified Flouroscopic X-Ray System.
Code Information Model No. 10849000; UDI: 04056869046877; Serial No. 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164161, 164152, 164069, 164086, 164084, 164158, 164188, 164105, 164080, 164011, 164100, 164097.
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactAnastasia Sokolova
610-219-4834
Manufacturer Reason
for Recall		Limited system movements after startup .
FDA Determined
Cause 2		Software design
ActionConsignees were mailed an URGENT: MEDICAL DEVICE CORRECTION notification dated 8/12/25. The notification informs consignees that the recall issue will be corrected via release of an Update Instruction AX032/25/S by appointment, which can be arranged by contacting 1-800-888-7436. Consignees are to disseminate the recall notification to all users of affected devices within their organization and to where product may be further distributed. Consignees are to return the completed recall response form via email to recallsandrefusals.team@siemens-healthineers.com or by certified mail.
Quantity in Commerce20 units
DistributionUS Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.
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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