Z-0762-2020Class II

iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with...

Name: Z-0762-2020 iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with...
Creator: Deerfield Imaging, Inc.
Published: 2019-11-26
License: https://open.fda.gov/license/

IMRIS Imaging, Inc. / initiated 2019-11-26 / Terminated / root cause: design

FDA source

Deerfield Imaging, Inc. began a recall of iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX... on 2019-11-26. FDA classified it as Class II and gives the reason as "There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0762-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-26
Posted: 2019-12-31
Terminated: 2020-08-04
Recalling firm: IMRIS Imaging, Inc.
Product: iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens Artis zee family (biplane or floor or ceiling mounted single plane) and the IMRIS Neuro 3T System. The System is a solution providing MRI scanning capabilities in the angiography room while retaining all functionality of Siemens Artis zee system. The System includes a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside RF room to facilitate intra-operative, interventional, and multi-room imaging. It also allows intra-operative or interventional imaging capabilities, while retaining all diagnostic functionality of a standard MRI system in the diagnostic room. The iMRX system allows for the sequential use of either MR imaging or X-ray fluoroscopic imaging of the head or chest for a single patient while positioned on a common fixed table either prior to, during or post clinical procedure. When these images are interpreted by a trained physician, they may assist in diagnosis during either neurovascular or cardiovascular interventionsa procedures. The iMRX system is designed such that the imaging sub-systems cannot operate simultaneously and only in accordance with their respective cleared intended use.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible
Root cause tag: design
FDA root cause: Component design/selection
Action: An Urgent Field Safety Notice letter was sent to customers on 11/26/2019 via FedEx.. The letter state the issue, potential risk, the actions to be taken, and stated that the device will be modified. Questions can be directed to the service line at 1-866-475-0525.
Quantity in commerce: 6
Distribution: CT, MA, VA. International distribution: Australia, Canada, and Qatar.
Product codes and lots: Serial Number: 146792, 153374, 153642, 153793, 153896, 154588.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0762-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0762-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-08	2019-12-31

Product code LNH

K101813Class IIImrx System V1 and Imrisnv/imriscardioImris, Inc. / cleared 2010-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)