DORO Easy-Connect Navigation Adaptor compatibility issue recall
Pro-Med Instruments is recalling the DORO Easy-Connect Navigation Adaptor due to potential compatibility problems that could affect positioning accuracy and navigation system function. The company distributed 217 units worldwide.
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: This is an FDA Class II recall of a medical device with a potential functional defect (compromised compatibility affecting positioning and navigation system function). Per the rubric, a risk-of-harm product where injury has not yet been reported falls under "High" severity, as the hazard is direct but no reported adverse events are mentioned in the source text.
Plain-English summary
Pro-Med Instruments Gmbh is recalling the DORO Easy-Connect Navigation Adaptor (Model/Item No. 1204.002) due to a potential compatibility issue. The defect could compromise compatibility, which may influence the positioning of the reference array and affect the function of the navigation system.
The affected product was distributed worldwide, including to US states in California, Colorado, Kentucky, Idaho, Illinois, Massachusetts, Missouri, North Carolina, New Jersey, New York, and Texas, as well as to numerous international countries.
A total of 217 units are affected by this recall. The specific serial numbers involved are documented by the manufacturer and the FDA.
Patients and healthcare providers who have received this device should contact Pro-Med Instruments Gmbh or the FDA for guidance on proper handling and potential replacement or repair options.
The recalled product
- Product
- DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
- Manufacturer
- Pro-Med Instruments Gmbh
- Hazard
- compatibility-defect
- navigation-system-malfunction
- positioning-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model/Item No: 1204.002
- UDI-DI: 04250435506738
- Serial numbers: 1102010
- 1201002
- 1201004
- 1201005
- 1201006
- 1201008
- 1201009
- 1201011
- 1206012
- 1206013
- 1206014
- 1206015
- 1206016
- 1206018
- 1310001
- 1310002
- 1310003
- 1312001
Distribution
Distributed nationwide across the United States.
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