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Brain, Spine Surgery Headrest Recall; Possible Serious Injury


On September 28, 2018, Pro-Med Instruments recalled its Doro Lucent Headrest System, including the Doro Lucent base unit, locking transitional member, and transitional member, because there is a risk the headrest system components may malfunction and fail.

 

The Doro Lucent Headrest System is used to support the head and neck during brain and spine surgeries when immobilization is required. Recent design revisions can prevent the headrest from fitting together properly if parts from different revisions are used together. The use of this combination of different revision parts may cause serious adverse health consequences or death.

 

The recalled parts were manufactured between May 4, 2017, and April 5, 2018, and were distributed between March 21, 2018, and July 5, 2018. The recalled parts bear the serial numbers 1704001, 1704042, 1709001, and 1709096.

 

Health care providers who use the Doro Lucent Headrest System for immobilization during brain and spine surgeries should discontinue the combined use of the two different design revisions of the Doro Lucent base unit, locking transitional member, and transitional member and isolate the products affected by this recall.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the Recall

 

See also Medical Law Perspectives Report: Spinal Cord Injury Malpractice: Back to Back Problems

 

See also Medical Law Perspectives Report: Brain Aneurysm and Subarachnoid Hemorrhage: Failure to Diagnose, Delayed Diagnosis, Misdiagnosis

 

 

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