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

FDA device recall Z-1803-2010 · posted 2010-06-15 · Terminated

Recall details

Recalling firm

Stryker Communications Corp

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

GCJ

Quantity affected

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.

Date initiated

2010-04-30

Date posted

2010-06-15

Date terminated

2011-04-25

Location

Flower Mound, TX

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