Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Recall
- Recall Number
- Z-2529-2025
- Event Number
- 97444
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- August 12, 2025
- Posted
- September 5, 2025
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418
Description
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Limited system movements after startup .
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 [email protected] or by certified mail.
US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.
20 units