The Recall Desk
SevereFDA (Devices)·Z-2972-2018·Announced 2018-09-26

Pro-Med DORO LUCENT Transitional Member Recall for Potential Malfunction

Pro-Med Instruments is recalling 31 DORO LUCENT Transitional Members because mixing design revisions may cause the headrest system to malfunction.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.

Plain-English summary

Pro-Med Instruments Gmbh is recalling 31 units of the DORO LUCENT Transitional Member (REF 1101.026). This component is part of a headrest system used in open and percutaneous craniotomies and spinal surgeries.

The recall is due to a potential malfunction and failure of the headrest system that could occur if two different design revisions of the DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member are combined in a single setup.

The affected units were distributed worldwide to the US states of CA, TX, TN, MS, GA, WV, and OH, as well as to Qatar, India, UK, Singapore, Australia, Germany, South Africa, Italy, and Japan. Specific serial numbers for the 31 units are listed in the official recall documentation. Healthcare facilities should check their inventory for these specific serial numbers and stop using the affected components.

The recalled product

Product
DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
Affected units
31

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 3 recalled by Pro-Med Instruments Gmbh under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →