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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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
- Affected units
- 217
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
Related recalls
Same manufacturer · Pro-Med Instruments Gmbh
See all →- SeverePro-Med DORO LUCENT Headrest System Recalled for Malfunction Risk
FDA (Devices) · 2018-09-26
- SeverePro-Med Instruments Recalls DORO LUCENT Locking Transitional Member
FDA (Devices) · 2018-09-26
- SeverePro-Med DORO LUCENT Transitional Member Recall for Potential Malfunction
FDA (Devices) · 2018-09-26
- HighPro-Med Instruments Recalls DORO Sterile Disposable Skull Pins Due to Breakage
FDA (Devices) · 2017-12-13
Similar recalls
- SeverePro-Med DORO LUCENT Headrest System Recalled for Malfunction Risk
FDA (Devices) · 2018-09-26
- SeverePro-Med DORO LUCENT Transitional Member Recall for Potential Malfunction
FDA (Devices) · 2018-09-26
- SeverePro-Med Instruments Recalls DORO LUCENT Locking Transitional Member
FDA (Devices) · 2018-09-26
- HighNavigation adapters recalled because the system may miss its specified accuracy
FDA (Devices) · 2025-11-12
- HighBodycad Torque Limiting Adaptor Recalled for Breakage Risk
FDA (Devices) · 2021-11-24
- ModerateBrainlab Curve Navigation Stations Recalled for Incorrect Manufacturer Calibration
FDA (Devices) · 2020-08-19