The Recall Desk
HighFDA (Devices)·Z-0646-2019·Announced 2018-12-26

Deerfield Imaging Recalls IMRIS ORT 100 Tables Due to Roll Drift

Deerfield Imaging is recalling 27 IMRIS ORT 100 tables because they may drift in the roll position during use, posing a risk of patient injury.

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 is classified as FDA Class II, and the hazard involves a mechanical defect in a medical device used during procedures that could lead to patient injury, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Deerfield Imaging, Inc. is recalling 27 units of the IMRIS ORT 100 table, specifically Part Numbers 110470-000 and 110470-600. The recall is being conducted by the U.S. Food and Drug Administration (FDA) under Class II classification. The affected tables are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient.

The recall is due to a defect where the table may drift in the roll position while in use. This unintended movement could potentially cause patient injury during medical procedures. The affected units were distributed worldwide, including in the United States, China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, and Italy.

Healthcare facilities and users of these tables should stop using the affected units immediately and contact Deerfield Imaging, Inc. for instructions on repair or replacement. The specific serial numbers for the affected units are listed in the official FDA recall notice Z-0646-2019.

The recalled product

Product
IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining f
Manufacturer
Deerfield Imaging, Inc.
Category
Medical Device — Imaging Table
Hazard
Affected units
27

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 (20)

  • (a) 110470-000
  • Serial Numbers: 10002845
  • 10002341
  • 10003629
  • 10003801
  • 10003830
  • 10002847
  • 10002796
  • 10003243
  • 10002654
  • 10003841
  • 10002607
  • 10007348
  • 10007424
  • 10005651
  • 10004250
  • 10004439
  • 10003241
  • 10006886
  • 10002848

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Deerfield Imaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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