- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
- Affected products (lot / model / serial)
- UDI 04056869046877
- Units affected
- 73
- Distribution pattern
- U.S. and O.U.S.
- Firm location
- Malvern, PA, United States
- Recall type
- FDA Mandated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1814-2026
- Recall initiated
- March 12, 2026
- FDA classification date
- April 16, 2026
- FDA report date
- April 22, 2026
- FDA event ID
- 98772
- Last updated on HTM Vibe
- July 24, 2026