FDAOctober 31, 2024device
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
What to do
FDA enforcement status: Ongoing
Brands named
hermes medical solutions abhermeshermes medical
UPCs
0085987300615800859873006196
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDALidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.2026-05-12
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- FDABrand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membra...2026-05-11
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