Class 2 Device Recall Visum Halogen Surgical Light

• Date Initiated by Firm: September 25, 2012
• Date Posted: January 09, 2013
• Recall Status: Terminated on April 22, 2013
• Recall Number: Z-0657-2013
• Recall Event ID: 63355
• Product Classification: Light, surgical, ceiling mounted - Product Code FSY
• Product: (l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigation Arm The Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light, (2)Visum LED Surgical Light, and (3)Stryker Flat Panel and Navigation Arm. The Spring Arm that is subject to this field action suspends loads, is a conduit for power/data, and facilitates multi-directional movement. The Spring Arms that have been identified within scope are replacement parts that have potentially been serviced incorrectly.
• Code Information: Code Number and Product Name: 0682000112-SPRING ARM, LIGHT 12-18KG, 0682000211 - FLAT PANEL SPRING ARM, ONDAL SUSPENSION, 15-21KG, 0682000212 - FLAT PANEL SPRING ARM, ONDAL SUSP., 12-18KG, 0682000226 - SPRING ARM,3.5-7KG,NAVIGATION, 0682000228 - SPRING ARM, LIGHT 9-15KG, 0682001062 - PKG EDS LIGHT SUSPENSION CENTRAL AXIS 5P/FP, 0682001270 - 9-POLE SPRING ARM, AC 2000,15-21 KG, 0682001274 - 5-POLE SPRING ARM AC 2000 15-21 KG, 0682400034 - FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG, 0682400059 - UNIVERSAL YOKE SPRING ARM RETROFIT KIT, 06824000591 - UNIVERSAL YOKE & SPRING ARM RETROFIT KIT, INT, 0682400151 - LOW CEILING SPRING ARM, 5P SIDE MOUNT, 0682400152 - LOW CEILING SPRING ARM, 9P SIDE MOUNT, 0682400169 - 5-POLE SPRING ARM AC 2000 9-15KG, CARDINAL, 0682400207 - STANDARD SPRING ARM WITH BEARING, 5P, 0682400208 - STANDARD SPRING ARM WITH BEARING, 9P, and 0682400365 - FLAT PANEL SPRING ARM WITH ERA ADAPTER BEARING.
• Recalling Firm/ Manufacturer: Stryker Communications, Inc.; 1410 Lakeside Pkwy Ste 100; Flower Mound TX 75028-4026
• For Additional Information Contact: Nicole Kubat; 972-410-7100
• Manufacturer Reason for Recall: Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not fully seated, the Spring Arm could separate and fall along with the surgical lights or monitors mounted to the end of the Spring Arm. To date, there have been no serious injuries reported from the incomplete e
• FDA Determined Cause: Equipment maintenance
• Action: Stryker sent an Urgent Medical Device Correction letter dated September 25, 2012, to all affected customers. The letter identified the product, the prolem, and the action to be taken by the customer. Customers were instructed to immediately inspect their Spring Arm. If customers experienced any concerns with their Spring Arm they were instructed to contact Stryker immediately at 1-866-841-5663 to schedule a service technician to inspect and correct the Spring Arm circlips. For questions regarding this recall call 972-410-7100.
• Quantity in Commerce: United States: 1,082 units and Outside United States: 199 units
• Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Japan, Taiwan, Canada, United Kingdom, France, Netherlands, Spain, Mexico, India, Korea, Singapore, New Zealand, Hong Kong, Philippines and Brazil.
• 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.