- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
- Affected products (lot / model / serial)
- UDI: 4056869046877
- Distribution pattern
- US and Worldwide
- Firm location
- Malvern, PA, United States
- Recall type
- FDA Mandated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2205-2026
- Recall initiated
- March 9, 2026
- FDA classification date
- June 4, 2026
- FDA report date
- June 10, 2026
- FDA event ID
- 98992
- Last updated on HTM Vibe
- July 24, 2026