Hermes Medical Solutions AB: Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0

Hazard

Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.

Details from the source

Reason for recall: Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study. Distribution: U.S.: CA, CT, FL, HI, KY, MA, MD, MO, NJ. NY, OH, TN, TX, VA, and WA O.U.S.: Germany, and United Kingdoms Quantity: 778 systems Lot/code info: Hermes Medical Imaging System version 6.1 with Hybrid Recon version 4.0.x UDI-DI code: 00859873006158 Serial Numbers: Pending Hybrid Recon version 5.0.0 UDI code: (01)00859873006196(8012)005000000 Serial Numbers: Pending

UPC codes

00859873006158, 00859873006196

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.