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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used in neurosurgery where a malfunction could lead to patient injury, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
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
- 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.
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