ExacTrac 6 — Class II medical device recall Z-2440-2015
Terminated recall by Brainlab AG, reported 2015-09-02, distributed in AK, AL, AZ, CA, CO, CT, FL, GA…. ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (
| Recall number | Z-2440-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, N/A, Germany |
| Recall initiated | 2015-08-05 |
| Classified | 2015-08-21 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2017-01-05 |
| Distributed | AK, AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, NC, ND, NE, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, DE, DK, ES, FI, FR, GB, HK, IL, IN, IT, JP, KR, NL, PA, QA, RU, SI, TH, TR, TW, ZA |
| Quantity | 361 systems |
| Model numbers | 70359-01 |
Product
ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
Reason for recall
ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.
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-2440-2015. 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.