Device Recall IMRIS ORT100 Table 의 리콜

Recall

79488

Class 2

Z-1263-2018

2018-02-23

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162455

The operating room table may drift while in use, which could potentially result in unintended movement of the table.

The firm initiated their field notification on 02/23/2018 by letter. The notice stated the following: "It has recently come to our attention that the ORTT2X/100/200/300 tables may drift while in use, which could potentially result in unintended movement of the table. This may pose a risk of injury to the patient. To minimize these risks, IMRIS is taking the following corrective actions: " ORT T2X/100/200 tables: The tables will be tested for drift symptoms. No further action will occur for tables that pass the drift test. For tables that do not pass the drift test, a hydraulc fluid flush and filter change will be performed. " ORT300 tables: all customer sites with these tables shall have the hydraulic fluid flushed and exchanged for new and the filter element will be changed.A drift test will also be performed. IMRIS has identified that your facility has one or more of these OR Tables which require evaluation. Please confirm details on page 2 and return your response to IMRIS. IMRIS Customer Service will contact you to implement this corrective action. IMRIS recommends these preventive actions: " Per the ORT Operator Manuals, the table should be tested daily in all standard positions and inspected for anomalies. Before each surgery, inspect the table for any visibly loose components or hydraulic fluid leaks and check that the headrest and tabletop safety latches are secured. .Please contact customer support via our service line at 1-866-475-0525 or Email: customersupport@imris.com if you have any questions or concerns."