The Recall Desk
HighFDA (Devices)·Z-0428-2013·Announced 2012-11-28

IMRIS OR Tables Recalled Due to Magnet Attraction Risk

IMRIS is recalling ORT100 and ORT200 tables used in MRI systems because the foot end may be attracted to the magnet, posing a risk of injury to patients and operators.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Innovative Magnetic Resonance Imaging Systems Inc. (IMRIS) is recalling the ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00) operating room tables. These tables are used in the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems. The recall involves 23 units distributed nationwide, including in Florida, Georgia, Indiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Tennessee, Utah, and Virginia.

The recall was initiated because, if proper procedure is not followed, the foot end of the 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.

The source text does not specify specific actions for consumers or healthcare providers beyond the initiation of the recall.

The recalled product

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.
Affected units
23

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • 10002845
  • 10002341
  • 10003244
  • 10002794
  • 10003243
  • 10003629
  • 10003801
  • 10002654
  • 10002796
  • 10002795
  • 10002846
  • 10002847
  • 10003830
  • 10003064
  • 10005201
  • 10003754
  • 10004513

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically: