Brainlab Cranial Navigation System: An Image Guided Surgery System /… — Class I medical device recall Z-0598-2016
Terminated recall by Brainlab AG, reported 2016-01-27, distributed nationwide. Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccurac
| Recall number | Z-0598-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Munich, N/A, Germany |
| Recall initiated | 2013-04-22 |
| Classified | 2016-01-19 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2018-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HN, HU, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KR, LT, LV, MA, MX, MY, NL, NO, OM, PA, PH, PK, PL, PT, QA, SA, SE, SG, SI, SK, TH, TR, TT, TW, UA, VE, VN, ZA |
| Reason classes | software |
| Serial numbers | 00000, 000000000005412001, 000000000034814001, 000000000034914001, 000000000051714001, 000000000052612001, 000000000052712001, 000000000055912001, 000000000059214001, 000000000060612001, 000000000108312001, 000000000108412001, 000000000108512001, 000000000110212001, 000000000157012001, 000000000239112001, 000000000239212001, 000000000239312001, 000000000239512001, 000000000240112001, 000000000240212001, 000000000246112001, 000000000251912001, 000000000253112001, 000000000254712001 and 475 more |
| Model numbers | 1.0, 22035, 22040, 22040-02, 22040-11, 22040B, 22040C, 22040D, 22040E, 22040F, 22040H, 22043, 22204-02, 22204B, 22204C, 22204D, 22204E, 22207, 22207A, 22208, 22208-11, 22208A, 22214, 22214-01, 22214-01A and 35 more |
Product
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
Reason for recall
Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0598-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.