Luminos dRF Max (VE10, VF10, VF11)
Reported: May 31, 2023 Initiated: November 23, 2022 #Z-1480-2023
Product Description
Luminos dRF 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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 704 units in the United States (1945 units worldwide)
- Distribution
- US Nationwide - Worldwide Distribution
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Luminos dRF Max (VE10, VF10, VF11). Recalled by Siemens Medical Solutions USA, Inc. Units affected: 704 units in the United States (1945 units worldwide).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2023. Severity: Moderate. Recall number: Z-1480-2023.
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