The Recall Desk
HighFDA (Devices)·Z-2586-2021·Announced 2021-10-06

Operating room table rotational lock may fail to maintain position

The rotational lock on certain operating room tables may fail to secure the table position. This could cause the table to move unexpectedly during diagnostic or surgical procedures.

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: This is a Class II FDA recall of a surgical positioning device where the hazard—rotational lock failure—creates a risk to patient positioning during procedures. No injuries or illnesses have been reported in the source text, so the score is High (3) per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Deerfield Imaging, Inc. is recalling operating room tables due to a potential failure in the rotational lock mechanism. The lock may fail to change states between locked and unlocked positions due to a mechanical hardware issue.

The affected operating room tables are used in diagnostic examinations, radiologic procedures, and surgical operations to support and position patients. If the rotational lock fails to engage properly, the table position may change unexpectedly during a procedure, potentially placing patients at risk.

Three units are affected with the following serial numbers: 10007411, 10002996, and 10004515 (Model 114093-600, UDI 00857534006462). These units have been distributed worldwide to facilities in the United States (Florida, New Hampshire, Texas, Ohio, California, Oregon, Utah, Tennessee, North Carolina) and internationally to Canada, Australia, Sweden, and Japan.

If you have one of the affected units, contact Deerfield Imaging, Inc. immediately to discuss the issue and any corrective actions. Healthcare facilities should inspect their equipment and document any history of lock malfunction or positioning problems.

The recalled product

Product
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Manufacturer
Deerfield Imaging, Inc.
Hazard
  • mechanical-failure
  • positioning-hazard

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 (5)

  • UDI: 00857534006462
  • Model Number: 114093-600
  • Serial Number: 10007411
  • 10002996
  • 10004515.

Distribution

Distributed nationwide across the United States.