RecallDepth

Luminos dRF Max (VE10, VF10, VF11)

Company
Siemens Medical Solutions Usa, Inc
Recall Initiated
November 23, 2022
Posted
May 23, 2023
Recall Number
Z-1480-2023
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.

Distribution

US Nationwide - Worldwide Distribution

Lot / Code Info

Model: 10762471

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

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