Stryker Communications Corp: 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.

Recall number

Z-1803-2010

Recalling firm

Stryker Communications Corp

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.

Status

Terminated

Initiated

2010-04-30

Posted

2010-06-15

Terminated

2011-04-25

Reason

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.

Root 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

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.

Lot, serial or model codes

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

510(k) numbers

["K033132"]

PMA numbers

not on file

Product code

GCJ

Firm FEI

3002975342

Firm city

Flower Mound

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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