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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 00857534006356

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

What happened

Deerfield Imaging, Inc. is recalling operating room tables due to a mechanical hardware issue affecting the rotational lock on ORT200/300 models. The lock may fail to function properly and become unable to change between locked and unlocked states. A total of 10 units have been distributed worldwide across multiple U.S. states and internationally to Canada, Australia, Sweden, and Japan.

The affected units can be identified by the model number 114093-000 and the specific serial numbers 10005695, 10002998, 10005456, 10007377, 10002997, 10006737, 10004372, 10002841, 10005613, and 10002255. The source document does not specify a remedy or corrective action for affected consumers.

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: 10 units Lot/code info: UDI: 00857534006356 Model Number: 114093-000; Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10006737, 10004372, 10002841, 10005613, and 10002255.

Source

Official record: FDA (Device enforcement) ↗

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

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