Z-1803-2010

The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE), an integrated voice, video, data router and...

Name: Z-1803-2010 The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE), an integrated voice, video, data router and...
Creator: Stryker Communications Corp
Published: 2010-04-30
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2010-04-30 / Terminated / root cause: design

FDA source

Stryker Communications Corp began a recall of The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE), an integrated voice, video, data router and teleconferencing interface for the operating room... on 2010-04-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1803-2010
Status: Terminated
Initiated: 2010-04-30
Posted: 2010-06-15
Terminated: 2011-04-25
Recalling firm: STRYKER Communications, Inc.
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: design
FDA 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 [email protected].
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.
Product codes and lots: 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

Product code GCJ

K033132Class IIStryker Switchpoint InfinityStryker Communications Corp. / cleared 2004-09-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)