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Terminated

SwitchPoint Infinity Control System Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 The SwitchPoint Infinity (SPI) Control System is an integrated voice, video, data router and teleconferencing interface for operating rooms. The SwitchPoint Infinity is used for direct control of room equipment, audio/video equipment, and indirect control of surgical equipment in the operating room.

FDA Recall Z-0136-2012 · Posted 2011-10-28

Recalling FirmStryker Communications Corp
Recall StatusTerminated
Product CodeFSY
Date Initiated2011-08-23
Date Terminated2012-08-20

Reason for Recall

Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate.

Firm Action

Stryker sent an URGENT FIELD SAFETY NOTICE: RA2010-245 dated August 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached Customer Response Form within 5 business days to Stryker. A Stryker representative would contact them at their convenience to schedule a re-inspection for all of the units identified and still in use. In the event the inspected equipment does not meet Stryker's established specifications, their representative will visit their facility and hopefully resolve the issue. If a subsequent visit is required the date will be scheduled in full consideration of their services. For questions regarding this recall call 972-410-7310.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution including Puerto Rico, Brazil, Ecuador, Venezuela, Costa Rico, Bolivia, Peru, Mexico, China, India, Korea, Philippines, Singapore, Malaysia, Taiwan, Middle East, Russia, Africa, Poland, South Africa, Australia, New Zealand, Canada, Japan, Denmark, Finland, Norway, Sweden, Belgium, The Netherlands, France, Germany, Austria, Italy, Portugal, Spain, Romania, Switzerland, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060802VISUM LED SURGICAL LIGHTING SYSTEMStryker Communications Corp. · 2006-04-07

Official Source

View FDA Recall →

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

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