Agency classClass IOur severity:Severe FDA (Devices)·Z-2971-2018·Announced 2018-09-26

Pro-Med Instruments Recalls DORO LUCENT Locking Transitional Member

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

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."

Plain-English summary

Pro-Med Instruments Gmbh is recalling 31 units of the DORO LUCENT Locking Transitional Member, REF 1101.031. This component is part of a headrest system used in open and percutaneous craniotomies and spinal surgeries.

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

The affected units were distributed worldwide to 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 are listed in the official recall notice. Healthcare facilities should stop using the affected components and contact the manufacturer for instructions.

The recalled product

Product: DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
Manufacturer: Pro-Med Instruments Gmbh
Category: Medical Device — Surgical Instrument
Hazard: malfunction
mechanical-failure
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 →

Same manufacturer · Pro-Med Instruments Gmbh

See all →

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FDA (Devices) · 2025-06-04
Severe
Pro-Med DORO LUCENT Headrest System Recalled for Malfunction Risk
FDA (Devices) · 2018-09-26
Severe
Pro-Med DORO LUCENT Transitional Member Recall for Potential Malfunction
FDA (Devices) · 2018-09-26
High
Pro-Med Instruments Recalls DORO Sterile Disposable Skull Pins Due to Breakage
FDA (Devices) · 2017-12-13

Same hazard · malfunction