FDAFDA · Food and drugs·Recall number Z-1860-2025
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Published June 4, 2025 · Recall initiated: March 14, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Pro-Med Instruments Gmbh
- Distributor
- 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.
- Lot
- 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, 1312002, 1312003, 1312004, 1312005, 1312006, 1312007, 1312008, 1312009, 1312010, 1407011, 1407012, 1407013, 1407014, 1407015, 1407016, 1407017, 1407018, 1407019, 1407020, 1501026, 1501027, 1501028, 1501029, 1501030, 1503031, 1503032, 1503033, 1503034, 1503035, 1503035, 1503036, 1503037, 1503038, 1503039, 1503040, 1505041, 1505042, 1505043, 1505044, 1505045, 1505046, 1505047, 1505048, 1505049, 1505050, 1506051, 1506052, 1506053, 1506054, 1507055, 1509056, 1509057, 1509058, 1509059, 1509060, 1509061, 1509062, 1509063, 1509064, 1509065, 1605066, 1605067, 1605068, 1605069, 1605070, 1605071, 1605072, 1605073, 1605074, 1605075, 1610078, 1610079, 1610080, 1610081, 1610082, 1610083, 1610084, 1610085, 1610086, 1708001, 1708002, 1708003, 1708004, 1708005, 1708006, 1708007, 1708008, 1708009, 1708010, 1801011, 1801012, 1801013, 1802014, 1802015, 1802016, 1802017, 1802018, 1802019, 1802020, 1805021, 1805022, 1805023, 1805024, 1805025, 1806026, 1806027, 1806028, 1806029, 1806030, 1807031, 1807032, 1807033, 1807034, 1811036, 1811037, 1811038, 1811039, 1811040, 1902001, 1902002, 1902003, 1902004, 1902005, 1902006, 1902007, 1902008, 1902009, 1902010, 1910001, 1910002, 1910003, 1910004, 1910005, 1910006, 1910007, 1910008, 1910009, 1910010, 2007001, 2007002, 2007003, 2007004, 2007005, 2007006, 2007007, 2007008, 2007009, 2007010, 2010001, 2010002, 2010003, 2010004, 2012001, 2012002, 2012004, 2012006, 2012007, 2012008, 2012009, 2012010, 2102001, 2104001, 2104002, 2104003, 2104004, 2104005, 2107001, 2107002, 2107006, 2107007, 2112001, 2112002, 2112003, 2202001, 2202002, 2202003, 2202004, 2202005, 2205001, 2205002, 2212001, 2212002, 2212003, 2212004, 2212005, 2301001, 2401001, 2401002, 2401003, 2401004, 2401005, 2401006, 2401007, 2405001, 2405002, 2405003, 2405004, 2408001, 2408002, 2408003, 2409001, 2409002, 2409003, 2409004;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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