The Recall Desk
HighFDA (Devices)·Z-1217-2018·Announced 2018-04-04

Deerfield Imaging Recalls ORT200 Operating Room Tables Due to Locking Mechanism Failure

Deerfield Imaging is recalling 17 IMRIS ORT200 operating room tables because their rotational locking mechanisms fail to operate, preventing the table from changing between locked and unlocked states.

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 compromise patient safety during procedures, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Deerfield Imaging, Inc. is recalling 17 units of the IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version. The recall is due to a defect in the rotational locking mechanisms, which fail to operate and prevent the table from changing states between locked and unlocked.

The affected tables are intended for use during diagnostic examinations or surgical procedures to support and position a patient. The recall covers units distributed in the US, Canada, China, Sweden, Germany, Japan, Qatar, France, and Australia. Specific serial numbers for the affected units are listed in the agency's recall record.

Healthcare facilities should stop using the affected tables and contact Deerfield Imaging, Inc. for instructions on how to resolve the issue.

The recalled product

Product
IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Affected units
17

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 (16)

  • Serial numbers: 10006997
  • 10002692
  • 10006152
  • 10007192
  • 10006991
  • 10002220
  • 10003754
  • 10006997
  • 10004513
  • 10005201
  • 10006891
  • 10004463
  • 10005189
  • 10005190
  • 10004327
  • 10004997

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 →