Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Check against the official notice below — it lists the full affected range.
Deerfield Imaging, Inc. is recalling operating room tables due to a mechanical hardware issue with the rotational lock that may prevent it from changing between locked and unlocked states. The recall affects 13 units distributed worldwide, including locations in the United States (Florida, New Hampshire, Texas, Ohio, California, Oregon, Utah, Tennessee, and North Carolina) as well as Canada, Australia, Sweden, and Japan. The affected tables include specific model and serial numbers: Model 113821-000 (Serial 10002220), Model 113821-600 (Serials 10002692, 10006152, 10006991, 10004513, 10006997, and 10003754), and Model 114148-000 (Serials 10004463, 10006891, 10005189, 10005190, 10004327, and 10004997).
The source document does not specify what actions affected consumers or healthcare facilities should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
Reason for recall: ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue. Distribution: Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan. Quantity: 13 units Lot/code info: UDI: 00857534006738 and 00857534006349 Model Number: 113821-000 (Serial Number: 10002220); 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.