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NORAS OR HEAD COIL Top Array Siemens 3T

Noras MRI products GmbH · Model 02 · UDI-DI 04251269206276

HBL Prescription

510(k) clearances

5,856

Adverse events (5 deaths)

Recalls

Facilities

Description

The intended use of the NORAS OR head coil, is in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).

Recalls

Date	Firm	Reason
2025-12-08	IMRIS Imaging Inc	Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alter
2025-03-14	Pro-Med Instruments Gmbh	Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded
2022-02-17	Deerfield Imaging, Inc.	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 around the axis) and
2020-11-11	Integra LifeSciences Corp.	Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
2019-06-26	Deerfield Imaging, Inc.	Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff
2018-07-05	Pro-Med Instruments Gmbh	The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and f
2018-07-05	Pro-Med Instruments Gmbh	The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and f
2018-07-05	Pro-Med Instruments Gmbh	The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and f
2017-11-02	Pro-Med Instruments Gmbh	The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part
2017-08-14	Deerfield Imaging	incorrect thread on thumbscrews

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.