Class 2 Device Recall DORO EasyConnect Navigation Adaptor

• Date Initiated by Firm: March 14, 2025
• Date Posted: May 28, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1860-2025
• Recall Event ID: 96720
• 510(K)Number: K001808
• Product Classification: Holder, head, neurosurgical (skull clamp) - Product Code HBL
• Product: DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
• 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
• FEI Number: 3003923584
• Recalling Firm/ Manufacturer: Pro-Med Instruments Gmbh; BOETZINGER STRASSE 86 ; Freiburg Im Breisgau Germany
• For Additional Information Contact: Mr. Nicholas Preissler; 239-369-2310
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: On March 14, 2025 URGENT FIELD SAFETY NOTICE letters were emailed to distributors and customers. 5. Actions to be taken by the Customer/User: If you receive this Field Safety Notice from pro med instruments GmbH, part of Black Forest Medical Group, you have been identified as a hospital or user that have been supplied with the concerned product. The hospitals/ users who are in possession with the concerned product are kindly requested to - review this notification and ensure that all your affected products are identified and removed from use. - discontinue the use of the concerned product. - complete the attached Acknowledgement and Receipt Form , select your desired corrective action type (repair by the manufacturer or repair on-site) and return it by fax or email to pro med instruments GmbH, part of Black Forest Medical Group to confirm receipt by March 28th, 2025, at the latest (see contact information under section 9. below). Repairs will be available from the 4th of April 2025 and can be conducted after receipt of the completed Acknowledgement and Receipt Form . If, after reviewing this notification, you have any further questions or queries please consult your DORO sales representative. 8. Type of Action by pro med instruments, part of Black Forest Medical Group: Immediate actions: " Identification of customers/ hospitals/ users with concerned products " Recall of concerned products " Information to relevant national competent authorities Corrective Actions: " Ensure that the affected devices in the field have been separated " Restore product compatibility of separated devices within the field through free-of-charge upgrades of recalled products by: o upgrading of returned devices by the manufacturer's service department o provision of spare parts for upgrading the returned devices by the user or an authorized DORO sales representative on-site " Ensure that there are no more defective products and associated subcomponents in the field.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HBL