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U.S. Department of Health and Human Services

Class 2 Device Recall SwitchPoint Infinity Control System

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  Class 2 Device Recall SwitchPoint Infinity Control System see related information
Date Initiated by Firm August 23, 2011
Date Posted October 28, 2011
Recall Status1 Terminated 3 on August 20, 2012
Recall Number Z-0136-2012
Recall Event ID 59866
510(K)Number K060802  
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product 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.
Code Information Catalog numbers: 0678000530, 0678000531, 0678000532, 0678000533, 0678000534, 0678000535, 0678000536, and 0678000537. Serial Numbers: All product distributed and installed between July 2004 and March 2011.
Recalling Firm/
Manufacturer		 Stryker Communications Corp
1410 Lakeside Pkwy Ste 100
Flower Mound TX 75028-4026
For Additional Information Contact Patricia Brown
972-410-7310
Manufacturer Reason
for Recall		 Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate.
FDA Determined
Cause 2		 Process control
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.
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FSY and Original Applicant = STRYKER COMMUNICATIONS CORP.
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