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.
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 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
- Manufacturer
- Pro-Med Instruments Gmbh
- Affected units
- 31
Distribution
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 →Related recalls
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