ClearanceBrief
Recall Z-0657-2013 ยท FSY Light, Surgical, Ceiling Mounted

Stryker Communications, Inc.

(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

DateJan 9, 2013 (initiated Sep 25, 2012)
StatusTerminated
ReasonStryker 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
Root causeEquipment maintenance
ActionStryker 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.
QuantityUnited States: 1,082 units and Outside United States: 199 units
DistributionWorldwide 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.