Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
- Recall Initiated
- August 12, 2025
- Posted
- September 5, 2025
- Recall Number
- Z-2529-2025
- Quantity
- 20 units
- Firm Location
- Malvern, PA
Reason for Recall
Limited system movements after startup .
Distribution
US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.
Lot / Code Info
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.
Root Cause
Software design
Action Taken
Consignees 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.