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Terminated

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.

FDA Recall Z-1803-2010 · Posted 2010-06-15

Recalling FirmStryker Communications Corp
Recall StatusTerminated
Product CodeGCJ
Date Initiated2010-04-30
Date Terminated2011-04-25
Product Quantity1,118 devices

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.

Firm 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 [email protected].

Root Cause

Component design/selection

Distribution Pattern

Worldwide distribution: USA and countries of Australia, EMEA, Canada, China, S. Africa, India, Japan, Latin America, Korea, Mexico, New Zealand, Taiwan, and Signapore.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033132STRYKER SWITCHPOINT INFINITYStryker Communications Corp. · 2004-09-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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