The Recall Desk
HighFDA (Devices)·Z-2584-2021·Announced 2021-10-06

Operating Room Table Rotational Lock May Fail Due to Hardware Defect

The rotational locking mechanism on certain ORT200/300 operating room tables may fail to lock or unlock due to a mechanical hardware defect. Affected tables have been distributed worldwide.

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 FDA Class II medical device recall involves a mechanical locking failure with no reported illnesses or injuries. The defect creates a risk-of-harm scenario for patient positioning and safety. Per the rubric, risk-of-harm products without reported injury score at 3 (High).

Plain-English summary

Deerfield Imaging, Inc. is recalling 13 ORT200/300 operating room tables because the rotational lock mechanism may fail to function properly. The rotational lock may not be able to change between locked and unlocked states due to a mechanical hardware defect.

The affected operating room tables are used during diagnostic examinations, radiologic procedures, and surgical operations to support and position patients. The inability to properly lock or unlock the table could create a safety concern during these procedures.

The 13 affected units have been distributed worldwide to healthcare facilities in Florida, New Hampshire, Texas, Ohio, California, Oregon, Utah, Tennessee, North Carolina, as well as Canada, Australia, Sweden, and Japan. Specific model and serial numbers are provided in the official recall notice.

Healthcare providers with affected equipment should contact Deerfield Imaging, Inc. to determine if their units are included in this recall and verify proper functioning of the rotational lock mechanism before continued use.

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.
Category
Medical Device — Surgical Equipment
Hazard
  • locking-mechanism-failure
  • patient-fall-risk

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 (12)

  • Model Number: 113821-600 (Serial Numbers: 10002692
  • 10006152
  • 10006991
  • 10004513
  • 10006997
  • and 10003754)
  • Model Number: 114148-000 (Serial Numbers: 10004463
  • 10006891
  • 10005189
  • 10005190
  • 10004327
  • and 10004997)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category