FDA Device recall Z-1481-2023
LUMINOS Lotus Max (VF11)
- FDA Device
- Class II
- ongoing
- Published 2023-05-31
On 2023-05-31 the FDA classified a Class II recall of LUMINOS Lotus Max (VF11) by Siemens Medical Solutions Usa, citing under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate rela….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1481-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-23 |
| Published | 2023-05-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
LUMINOS Lotus Max (VF11)
Reason
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.
Identifiers
| code_info | Model: 11574100 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1481-2023%22
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