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Recall Observatory FDA recall evidence

Device product

Stryker Visum 300 Ceiling-mounted Exam Light.

Z-1992-2013

July 25, 2013

Class II

Product summary

Firm
Stryker Communications
Event
Event 65888
Status
Terminated
Classification
Class II
Quantity
1,375 units
Official record key
device-enforcement:Z-1992-2013

Official wording

Reason: Potential incomplete final weld on the drop tube flange.

Code information: Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.

Distribution pattern: Worldwide Distribution: US natiowide and to the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential incomplete final weld on the drop tube flange.