FDA (Devices) recall action 88661
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
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.
The rotational lock on certain operating room tables may fail to secure the table position. This could cause the table to move unexpectedly during diagnostic or surgical procedures.
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.