Class I Recall of Pro-Med Instruments DORO LUCENT Headrest

PUBLISHED: Oct 1, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals

Pro-Med Instruments is recalling the DORO® LUCENT Base Unit, Locking Transitional Member, and Transitional Member because recent design revisions can prevent the headrest from fitting together properly if parts from different revisions are used together. The DORO Lucent Headrest System is used to support the head and neck during brain and spine surgeries when immobilization is required.

The use of this combination of different revision parts may cause serious adverse health consequences or death.

Recalled Product

  • Name: DORO® LUCENT Base Unit, Locking Transitional Member, and Transitional Member
  • Serial numbers: 1704001, 1704042, 1709001, 1709096
  • Manufacturing Dates: May 4, 2017 to April 5, 2018
  • Distribution Dates: March 21, 2018 to July 5, 2018
  • Devices recalled in the U.S: 73

On July 26, 2018, Pro-Med Instruments sent a Field Safety Notice to affected customers. The letter provided the following recommendations:

Health Care Providers

  • 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.
  • Contact Pro-Med Instruments for further instructions relating to temporary replacement possibilities.
  • Identify users who have been supplied with products of only revision B and inform them that they can continue use and that no further action is necessary.

Retailers and Distributors:

  • Identify users who have been supplied with any revision of the product and immediately forward the user’s contact information to Pro-Med Instruments and this Field Safety Notice.
  • Identify users who are in possession of products with two different revisions and who have been supplied with products of two different revisions. Immediately forward the contact information of users to Pro-Med Instruments.
  • Stop distributing products with revision A and return all products with revision A (your stock only) to Pro-Med Instruments.
  • Pro-Med Instruments will contact retailers and distributors regarding further instructions for the upgrade of concerned products from revision A to revision B. This action will prevent any possibility for future mix-ups of two different revisions.
  • Identify users who have been supplied with products of only revision B and inform them that they can continue use and that no further action is necessary.

Customers with questions may contact Jillian Forster, Quality Assurance Specialist for Pro-Med Instruments, at (239) 369-2310 Extension 114, Monday through Friday, from 8:30 AM to 5:30 PM Eastern Standard Time, or pmi.us@pmisurgial.com.

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