DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Reported: June 4, 2025 Initiated: March 14, 2025 #Z-1860-2025
Product Description
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Reason for Recall
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.
Details
- Recalling Firm
- Pro-Med Instruments Gmbh
- Units Affected
- 217 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, CO, KY, ID, IL, MA, MO, NC, NJ, NY, TX and the countries of Algeria, Argentina, Australia, Austria, Brazil, Burma, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Mexico, Mongolia, Netherlands, Norway, Philippines, Poland, Qatar, Russia, Russia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom.
- Location
- Freiburg Im Breisgau, N/A
Frequently Asked Questions
What product was recalled? ▼
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002). Recalled by Pro-Med Instruments Gmbh. Units affected: 217 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 4, 2025. Severity: Moderate. Recall number: Z-1860-2025.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11