Class 2 Device Recall SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE)

• Date Initiated by Firm: April 30, 2010
• Date Posted: June 15, 2010
• Recall Status: Terminated on April 25, 2011
• Recall Number: Z-1803-2010
• Recall Event ID: 55624
• 510(K)Number: K033132
• Product Classification: Laparoscope, general & plastic surgery - Product Code GCJ
• Product: The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE), an integrated voice, video, data router and teleconferencing interface for the operating room. The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE) are designed as an integrated voice, video, data router and teleconferencing interface for the operating room. The primary intent of the SPI2 and SPE product lines is to allow operating room personnel a center point for controlling all equipment and communication during surgery. The SPI2 and SPE route surgical and non-surgical images throughout the operating room to facilitate operating procedures. All video inputs and video outputs of the router require the use of various signal and cables types. Digital and analog video signals transmit from the auxiliary devices in the room through the SPI2 and SPE router to designated monitors. The primary difference between the SPI2 and SPE systems is that the SPE is a more compact version of the SPI2 offering less video inputs and outputs, and is intended to be used in smaller clinics.
• Code Information: Product/Catalog Numbers: 0100224307 (SPI2 128 MB DOM Card and 0100224592 (SPE DOM Card) Lot Code: All units distributed between 14 AUG 07 and 23 MAR 09
• Recalling Firm/ Manufacturer: Stryker Communications Corp; 1410 Lakeside Pkwy Ste 100; Flower Mound TX 75028-4026
• For Additional Information Contact: 972-410-7310
• Manufacturer Reason for Recall: Users may experience issues with the functionality of the SwitchPoint Infinity 2 and SwitchPoint Element that may be exhibited as a "Page Not Found" error message, missing drop down options, or a frozen touch panel.
• FDA Determined Cause: Component design/selection
• Action: The firm, Stryker, sent an "URGENT: Medical Device Correction" letter dated May 4, 2010, to all customers. The letter describes the product, problem and action to be taken by the customers. The firm recommended that the customer continue to use their SwitchPoint Infinity 2 or SwitchPoint Element. The customer is instructed to refer to their user manual, in the event they experience any failures; drive on module failure and/or product failure during a procedure. A Stryker representative will contact the customers facility to coordinate a service event to replace the existing component with a new component at no cost. Should the customer experience any of the aforementioned failures and require urgent technical support, please call Stryker Technical Support at 1-866-841-5663. If you have any questions regarding this letter or the implementation of this correction, please contact Shanta McKinzie at (972) 410-7319 or via email at StrykerCommunicationsRA@stryker.com.
• Quantity in Commerce: 1,118 devices
• Distribution: Worldwide distribution: USA and countries of Australia, EMEA, Canada, China, S. Africa, India, Japan, Latin America, Korea, Mexico, New Zealand, Taiwan, and Signapore.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GCJ