Strkyer Operating Room Surgical System Recall: Software May Freeze

About two dozen Operating Room System II Surgical Navigation Systems distributed worldwide by Stryker Corporation have been recalled because the screen the surgeon uses may slow down or freeze up.

The FDA posted notice of the Class I medical device recall on November 25 for the Navigation System II, which is a computer-aided surgery device used in a variety of surgeries, including neurological and ear, nose and throat surgery.

Although no injuries have been reported in connection to the defect, a failure during an operation could lead to neurological damage or death.

The problem occurs in the navigation PC SPC-1 component of the Navigation System II, a computer workstation. The component can stop working, which can result in the screen freezing, the screen updating at a slow rate, or the software can crash, causing the system to cease working.

The recall included 23 Operating Room System II Surgical Navigation Systems, which consists of the Navigation System II-Cart and the PC SPC-1 Assembly. The carts have a Stryker Catalog Number 7700-100-000, with serial numbers from 100715 through 100735. The PC SPC-1 Assembly has a Stryker Catalog Number 7700-101-201, with a lot number of K7P00F6000.

Hospitals which have the systems should quarantine them immediately and stop using them, Stryker and FDA recommended. Stryker notified customers by USPS and have repaired all the domestic systems, however, the devices were distributed worldwide. It was unclear from the recall how many of the systems were sold to U.S. hospitals or how many defective systems may still be in use in foreign operating rooms.

Any facility that has the system should contact Stryker Instruments. Health care professionals should report any adverse events with the Navigation System II to FDA’s MedWatch Adverse Event Reporting program.