The Recall Desk
HighFDA (Devices)·Z-0647-2019·Announced 2018-12-26

Deerfield Imaging Recalls IMRIS ORT 200 Tables Due to Roll Drift

Deerfield Imaging is recalling 14 IMRIS ORT 200 operating room tables because they may drift in the roll position while in use.

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 involves a risk-of-harm product (operating room table) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Deerfield Imaging, Inc. is recalling 14 units of the IMRIS ORT 200 Removable Operating Room Table. The affected units are identified by specific part numbers and serial numbers listed in the recall documentation. The tables are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient.

The recall was initiated because the table may drift in the roll position while in use. This defect could potentially affect patient positioning during procedures. The agency has classified this recall as Class II.

The affected units were distributed worldwide, including in the United States, China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, and Italy. Healthcare facilities that have these specific units should stop using them and contact Deerfield Imaging for instructions on corrective action.

The recalled product

Product
IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and po
Affected units
14

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)

  • (a) 113821-000
  • Serial Numbers: 10002220 (b) 113821-600
  • Serial Numbers: 10002692
  • 10006152
  • 10007192
  • 10006991
  • 10003754
  • 10006997
  • 10004513 (c) 114148-000
  • Serial Numbers: 10004463
  • 10005190
  • 10005189
  • 10006891
  • 10004997 (d) 114148-600
  • Serial Numbers: 10006891

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 →