Z-1479-2023 Class II Ongoing
FDA device recall Z-1479-2023 was initiated by Siemens Medical Solutions USA, Inc on Nov 23, 2022 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 704 units in the United States (1945 units worldwide).
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2023
- Initiation Date
- Nov 23, 2022
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 704 units in the United States (1945 units worldwide)
Product Description
Luminos Agile Max (VE10, VF10, VF11)
Reason for Recall
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. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.
Distribution Pattern
US Nationwide - Worldwide Distribution
Code Information
Model: 10762472
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1479-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026