Pro-Med Instruments Recalls the DORO LUCENT Headrest Due to Possible Malfunction and Failure

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries 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

Device Use

The DORO Lucent Headrest System is used to support the head and neck during brain and spine surgeries when immobilization is required. The headrest system has several parts including the base unit, the locking transitional member, and transitional member.

Reason for Recall

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

Name	Item No.	Revision A	Revision B
DORO LUCENT@ Base Unit	1101.021	Serial No. 1704001	Serial No. 1709001
DORO LUCENT' Locking Transitional Member	1101.031
DORO LUCENT@ Transitional Member	1101.026	Serial No. 1704042	Serial No. 1709096

Who May be Affected

Health care providers who use the DORO LUCENT Headrest System for immobilization during brain and spine surgeries.
Patients who require immobilization during brain and spinal surgeries.

What to Do

On July 26, 2018, Pro-Med Instruments sent a Field Safety Notice to affected customers. The letter provided the recommendations below for health care providers, retailers and distributors:

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.

Contact Information

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.

Date Recall Initiated

July 5, 2018

How Do I Report a Problem?

Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.