Z-0428-2013Class II

IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro...

Name: Z-0428-2013 IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro...
Creator: Innovative Magnetic Resonance Imaging Systems Inc.
Published: 2012-10-19
License: https://open.fda.gov/license/

Innovative Magnetic Resonance Imaging Systems, Inc. / initiated 2012-10-19 / Terminated / root cause: labeling and UDI

FDA source

Innovative Magnetic Resonance Imaging Systems Inc. began a recall of IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging... on 2012-10-19. FDA classified it as Class II and gives the reason as "IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0428-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-19
Posted: 2012-11-21
Terminated: 2012-12-11
Recalling firm: Innovative Magnetic Resonance Imaging Systems, Inc.
Product: IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Consignees were sent on 10/19/12 a IMRIS "Urgent Medical Device Correction" letter dated October 16. 2012. The letter described the product and the problem involved in the recall. It also provided changes to the Operator's Manual and labeling which addresses the issue. Customers may contact 1-866-475-0525.
Quantity in commerce: 23
Distribution: Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA.
Product codes and lots: 10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0428-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0428-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21

Product code LNH

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)