Visum LED Surgical Lights/ Visum Halogen Surgical Lights. Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 Visum LED Surgical Lights and Visum Halogen Surgical Lights are ceiling mounted devices which provide illumination via LED lights and halogen bulbs. All systems are ceiling or wall mounted lights and each provides sufficient illumination with high intensity light for all types of surgical procedures.
This recall has been terminated (originally issued October 28, 2011).
- Company
- Stryker Communications Corp
- Recall Initiated
- August 23, 2011
- Posted
- October 28, 2011
- Terminated
- August 20, 2012
- Recall Number
- Z-0137-2012
- Firm Location
- Flower Mound, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate.
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.
Lot / Code Info
Catalog numbers: 0682001250, 0682001251, 0682000106, and 0682000107. All product distributed and installed between July 2004 and March 2011.
Root Cause
Process control
Action Taken
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.