DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
This recall is currently active, issued May 28, 2025. It was issued by Pro-Med Instruments Gmbh Boetzinger Strasse 86 Freiburg Im Breisgau Germany.
- Recall Initiated
- March 14, 2025
- Posted
- May 28, 2025
- Recall Number
- Z-1860-2025
- Quantity
- 217 units
- Official Source
- View on FDA website ↗
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
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 Info
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;
Root Cause
Device Design
Action Taken
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.