The Recall Desk
HighFDA (Devices)·Z-1266-2018·Announced 2018-04-04

Deerfield Imaging Recalls IMRIS ORT300 Operating Room Tables Due to Drift Risk

Deerfield Imaging is recalling 13 IMRIS ORT300 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 13 units of the IMRIS ORT300 Removable Operating Room Table. The affected units include part numbers 114093-000 and 114093-600. The recall is due to a defect where the operating room table may drift while in use.

This drift could potentially result in unintended movement of the table. The affected units were distributed in the United States, Canada, China, Australia, Sweden, and Germany.

Healthcare facilities should contact Deerfield Imaging, Inc. for instructions on how to address the defect. Specific serial numbers for the affected units are listed in the official recall documentation.

The recalled product

Product
IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
Manufacturer
Deerfield Imaging, Inc.
Category
Medical Device — Operating Room Table
Hazard
Affected units
13

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 (14)

  • (a) 114093-000
  • Serial Numbers: 10005695
  • 10002998
  • 10005456
  • 10007377
  • 10002997
  • 10005612
  • 10004372
  • 10002841
  • 10002255
  • 10005613 (b) 114093-600
  • Serial Numbers: 10007411
  • 10002996
  • 10004515

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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