Pro-Med Instruments Gmbh: DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

Recall number

Z-1860-2025

Recalling firm

Pro-Med Instruments Gmbh

Product

DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

Status

Open, Classified

Initiated

2025-03-14

Posted

2025-05-28

Terminated

not on file

Reason

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.

Root 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

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.

Lot, serial or model codes

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;

510(k) numbers

["K001808"]

PMA numbers

not on file

Product code

HBL

Firm FEI

3003923584

Firm city

Freiburg Im Breisgau

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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