DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
FDA Device Recall #Z-1860-2025 — Class II — March 14, 2025
Recall Summary
| Recall Number | Z-1860-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 14, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Pro-Med Instruments Gmbh |
| Location | Freiburg Im Breisgau, N/A |
| Product Type | Devices |
| Quantity | 217 units |
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.
Distribution Pattern
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 / Code Information
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;
Other Recalls from Pro-Med Instruments Gmbh
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2972-2018 | Class I | DORO LUCENT Transitional Member, REF 1101.026 ... | Jul 5, 2018 |
| Z-2970-2018 | Class I | DORO LUCENT Base Unit, REF 1101.021 Headrest S... | Jul 5, 2018 |
| Z-2971-2018 | Class I | DORO LUCENT Locking Transitional Member, REF 11... | Jul 5, 2018 |
| Z-0193-2018 | Class II | pmi, pro med instruments, DORO(R) Sterile Dispo... | Nov 2, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.