The Recall Desk
HighFDA (Devices)·Z-0975-2018·Announced 2018-03-21

Deerfield Imaging Recalls IMRIS ORT100 Tables Due to Locking Mechanism Defect

Deerfield Imaging is recalling 15 IMRIS ORT100 tables because the rotational locking mechanisms can disengage, 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 structural defect in a medical device that could cause unintended movement, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Deerfield Imaging, Inc. is recalling 15 IMRIS ORT100 Tables, Part Number 110470-000. The recall affects specific serial numbers listed in the agency documentation. These devices were distributed in the United States, Canada, Australia, China, and Qatar.

The recall is due to a defect in the rotational locking mechanisms on the ORT 100/T2X tables. These mechanisms can become disengaged or unlocked while the table is in use. This failure could potentially result in unintended movement of the table.

Healthcare facilities and users should identify if they possess any of the affected serial numbers. They should contact Deerfield Imaging, Inc. for instructions on how to address the defect.

The recalled product

Product
IMRIS ORT100 Table, Part Number 110470-000
Manufacturer
Deerfield Imaging, Inc.
Category
Medical Device — Surgical Table
Hazard
Affected units
15

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 (15)

  • Serial Numbers: 10002341
  • 10003629
  • 10003801
  • 10002654
  • 10002795
  • 10002796
  • 10002847
  • 10003830
  • 10003243
  • 10002848
  • 10003241
  • 10005651
  • 10007348
  • 10007424
  • 10006886

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Deerfield Imaging, Inc.

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Same hazard · unintended movement

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