Digital Lightbox — Class II medical device recall Z-0218-2016
Terminated recall by Brainlab AG, reported 2015-11-11, distributed nationwide. Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.
| Recall number | Z-0218-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, N/A, Germany |
| Recall initiated | 2015-09-21 |
| Classified | 2015-11-05 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2017-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, HK, HU, IE, IL, IN, IR, IT, JP, LT, MA, MT, MX, MY, NL, NO, NZ, PH, PL, PT, QA, SA, SE, SG, TH, TR, TW, VN, ZA |
| Quantity | 897 |
| Model numbers | 15600, 25121-01 |
Product
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.
Reason for recall
Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.
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-0218-2016. 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.