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.

If you believe that you have been injured by this product, call The ML Firm for a free consultation at 512-330-9001.

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