Safety Alert Summary

Medical Device Safety Alert: Hyperfine Inc (Sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia) Swoop Portable MR Imaging System Mk 1.8 [Model Number: 900-11001-05; Serial numbers: HG21360037, HG21360038, HG21360039, HG21360040, HG21360041], Swoop Portable MR Imaging System Mk 1.9 [Model number: 900-11001-06; Serial numbers: HG23280042, HG23280043, HG23280045]

13 Sep 2024