Pro-Med DORO LUCENT Headrest System Recalled for Malfunction Risk
Pro-Med Instruments is recalling 30 DORO LUCENT Headrest Systems because mixing design revisions may cause malfunction during surgery.
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 recall involves a structural defect in a surgical device used for craniotomies and spinal surgeries, which poses a significant risk of injury or property damage if the system fails during a procedure.
Plain-English summary
Pro-Med Instruments Gmbh is recalling 30 units of the DORO LUCENT Base Unit, REF 1101.021 Headrest System. This medical device is used in open and percutaneous craniotomies and spinal surgeries.
The recall is due to a design issue where combining 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.
Healthcare facilities should identify the affected units by checking the serial numbers listed in the recall notice. Users should stop using the affected headrest systems and contact Pro-Med Instruments for instructions on return or replacement.
The recalled product
- Product
- DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
- Manufacturer
- Pro-Med Instruments Gmbh
- Affected units
- 30
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.
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