Luminos Agile Max (VE10, VF10, VF11)
- Recall Initiated
- November 23, 2022
- Posted
- May 23, 2023
- Recall Number
- Z-1479-2023
- Quantity
- 704 units in the United States (1945 units worldwide)
- Firm Location
- Malvern, PA
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
US Nationwide - Worldwide Distribution
Lot / Code Info
Model: 10762472
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Siemens Medical Solutions USA, Inc., will provide software updates to the affected systems with software versions VF10 and VF11 with software via Update Instructions (UI) XP007/23/S, XP004/23/S, XP003/23/S, and XP001/23/S