Operating Room Table Rotational Lock May Fail to Function
Deerfield Imaging operating room tables (ORT200/300) may have a mechanical defect in the rotational lock, preventing it from changing between locked and unlocked states. This could affect patient positioning during 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 an FDA Class II recall of a mechanical defect in operating room table equipment that affects a critical patient-positioning function. While no injuries have been reported, the failed rotational lock presents a risk of harm during surgical procedures, meeting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Deerfield Imaging, Inc. manufactures operating room tables (model ORT200/300) intended for use during diagnostic examinations, radiologic procedures, and surgical procedures. These tables are designed to support and position patients during medical procedures.
The recalled tables have a mechanical hardware defect affecting the rotational lock. The lock may fail to function properly and cannot reliably change between locked and unlocked states, potentially affecting the table's ability to maintain proper patient positioning during procedures.
A total of 10 units are affected by this defect. These units have been distributed across the United States (including Florida, New Hampshire, Texas, Ohio, California, Oregon, Utah, Tennessee, and North Carolina) and internationally to Canada, Australia, Sweden, and Japan.
This recall was issued due to the mechanical defect in the rotational lock mechanism that could impact patient safety during surgical and diagnostic procedures.
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-defect
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 (11)
- UDI: 00857534006356 Model Number: 114093-000
- Serial Numbers: 10005695
- 10002998
- 10005456
- 10007377
- 10002997
- 10006737
- 10004372
- 10002841
- 10005613
- and 10002255.
Distribution
Distributed nationwide across the United States.
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