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.