The Recall Desk
HighFDA (Devices)·Z-1263-2018·Announced 2018-04-04

Deerfield Imaging Recalls IMRIS ORT100 Operating Room Tables

Deerfield Imaging is recalling 26 IMRIS ORT100 operating room tables because they may drift during use, potentially causing unintended movement.

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 medical device with a mechanical defect that could cause unintended movement during use, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Deerfield Imaging, Inc. is recalling 26 units of the IMRIS ORT100 Operating Room Table. The affected units include part numbers 110470-000 and 110470-600. The recall covers specific serial numbers listed in the agency's structured data.

The recall was initiated because the operating room table may drift while in use. This defect could potentially result in unintended movement of the table during procedures.

The affected products were distributed in the United States, Canada, China, Australia, Sweden, and Germany. Users of these devices should contact Deerfield Imaging, Inc. for further instructions on how to address the issue.

The recalled product

Product
IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600
Manufacturer
Deerfield Imaging, Inc.
Category
Medical Device — Operating Room Table
Hazard
Affected units
26

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
  • 10002654
  • 10002795
  • 10002796
  • 10002847
  • 10003830
  • 10003243
  • 10003241
  • 10002607
  • 10002848
  • 10005651
  • 10007348
  • 10007424
  • 10004250
  • 10004439
  • 10004576

Distribution

Distribution scope not specified by the agency.

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 →

Related recalls

Same manufacturer · Deerfield Imaging, Inc.

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Same hazard · unintended movement

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