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FDA (Device enforcement)Recalled 2021-08-25closedclass ii

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

Is my product affected?

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

  • UPC 00857534006462

Check against the official notice below — it lists the full affected range.

What happened

Deerfield Imaging, Inc. is recalling three operating room tables due to a mechanical hardware issue with the rotational lock mechanism. The affected tables may fail to change states between locked and unlocked positions, which could impact the ability to properly position patients during diagnostic examinations, radiologic procedures, or surgical procedures. The recalled models (Model Number 114093-600) have serial numbers 10007411, 10002996, and 10004515, and were distributed worldwide to locations in the United States, Canada, Australia, Sweden, and Japan.

The source document does not specify a remedy or recommended action for consumers who may have affected equipment.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

Details from the source

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: 3 units Lot/code info: UDI: 00857534006462; Model Number: 114093-600; Serial Number: 10007411, 10002996, 10004515.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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