Deerfield Imaging, Inc.

Code	Device name	Class	Specialty	Clearances	Most recent
LNH	System, Nuclear Magnetic Resonance Imaging	Class II	Radiology	2	2024-02-15

Date	Severity	Status	Recall #	Product	Code	Reason
2022-02-17	Class II	Terminated	Z-0934-2022	Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation d…	—	Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally …
2021-08-25	Class II	Terminated	Z-2586-2021	Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical…	—	ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
2021-08-25	Class II	Terminated	Z-2585-2021	Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical…	—	ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
2021-08-25	Class II	Terminated	Z-2584-2021	Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical…	—	ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

Date	K-number	Device	Code	Class	Specialty
2024-02-15	K240157	InVision 1.5 Surgical Theatre	LNH	Class II	Radiology
2021-08-23	K212367	IMRIS iMRI 3T V	LNH	Class II	Radiology

Clearance cadence by quarter