[pending] DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Pending LLM rewrite. Source: FDA_DEVICE Z-1860-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
The recalled product
- Product
- DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
- Manufacturer
- Pro-Med Instruments Gmbh
- Category
- Medical Device — Devices
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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