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Stryker Communications, Inc. recalls (l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigation Arm The Spring
Recalled January 16, 2013 · FDA recall Z-0657-2013 · Stryker Communications
Hazard
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 Class II
Units
United States: 1,082 units and Outside United States: 199 units
Sold at
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.
Description
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
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.
Manufacturer(s)
Stryker Communications, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →