Doro Radiolucent Headrest System and Horseshoe Headrests, and Non-Radiolucent J-Arm Retractor System (Aluminum Alloy)

• 3 recalls, same reason

  • Terminated Z-2970-2018 FDA Class I ·initiated 5 Jul 2018
  • Terminated Z-2972-2018 FDA Class I ·initiated 5 Jul 2018
  • Terminated Z-2971-2018 FDA Class I ·initiated 5 Jul 2018

  The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.

510(k) Number

K032331 ↗

FDA Product Code

HBL

Device Class

Class II

Regulation

21 CFR Part 882.4460

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Doro Radiolucent Headrest System ( Also MRI-Compatible) and Components

  Class II

  FDA 510(k) K063494 Active Cleared 21 May 2007

• DORO LUCENT® iXI and iMRI Headrest System

  Class II

  FDA 510(k) K191740 Active Cleared 21 Feb 2020

• Doro Non-Stick Bipolar Forceps, Model 5001-Xx to 5012-Xx, Doro Bipolar Reusable Cables, Model 5015-Xx

  Class II

  FDA 510(k) K070997 Active Cleared 16 May 2007

• DORO QR3 XTom Headholder System

  Class II

  FDA 510(k) K191979 Active Cleared 22 Oct 2019

• DORO Sterile Disposable Skull Pins (36 pcs) (3006-00, 3006-10, 3006-20, 3006-30, 3006-50)

  Class II

  CE/MDR 1000297665 Active Valid to Jul 2028 FDA 510(k) K241883 Active Cleared 26 Jul 2024 +1authorizations

• Doro Lucent Skull Clamp (1101.001); Doro Lucent Skull Clamp Pediatric Set (1101.040)

  Class II

  FDA 510(k) K240319 Active Cleared 24 Apr 2024

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