Z-1860-2025Class II

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

Name: Z-1860-2025 DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Creator: Pro-Med Instruments Gmbh
Published: 2025-03-14
License: https://open.fda.gov/license/

Black Forest Medical GmbH / initiated 2025-03-14 / Open, Classified / root cause: design

FDA source

Pro-Med Instruments Gmbh began a recall of DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002) on 2025-03-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1860-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-14
Posted: 2025-05-28
Recalling firm: Black Forest Medical GmbH
Product: DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Product code: HBL Holder, Head, Neurosurgical (Skull Clamp)
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.
Root cause tag: design
FDA 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 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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1860-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1860-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-28

Product code HBL

K001808Class IIDoro Headrest SystemPro-Med Instruments GmbH / cleared 2000-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)