FDA Recalls of Image Guidance Systems for Sinus and Skull Base Surgery, 2003–2024
IGS have been subject to FDA recalls. Surgeons should avoid overreliance on IGS when planning and performing procedures. Manufacturers and FDA should resolve recalls in a timely manner to support safe surgery.
Authors
- Kyle C. Wu
- Vinay K. Rathi (ORCID: https://orcid.org/0000-0002-9763-9075)
- Stacey T. Gray
- Alan D. Workman (ORCID: https://orcid.org/0000-0001-9573-6472)
- Rodney J. Schlosser (ORCID: https://orcid.org/0000-0001-6480-0275)
- Thriaksh Rajan (ORCID: https://orcid.org/0009-0007-0586-1343)
- Patrick C. Walz (ORCID: https://orcid.org/0000-0003-2511-5210)
- Ralph Metson
- Zachary M. Soler (ORCID: https://orcid.org/0000-0002-4304-595X)
Institutions
- Massachusetts Eye and Ear Infirmary (US)
- Nationwide Children's Hospital (US)
- Medical University of South Carolina (US)
- The Ohio State University Wexner Medical Center (US)
- Ralph H. Johnson VA Medical Center (US)
- University School (US)
- The Ohio State University (US)
- Case Western Reserve University (US)
Publication Details
- Journal
- International Forum of Allergy & Rhinology
- Published
- 2025-05-14
- DOI
- https://doi.org/10.1002/alr.23590
- Primary Topic
- Pituitary Gland Disorders and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- National Institutes of Health
- National Institute on Deafness and Other Communication Disorders