Patient Data Manager 2 — Class II medical device recall Z-2134-2014
Terminated recall by Brainlab AG, reported 2014-08-06, distributed nationwide. The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including su
| Recall number | Z-2134-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, Germany |
| Recall initiated | 2014-06-27 |
| Classified | 2014-07-30 |
| Reported by FDA | 2014-08-06 |
| Terminated | 2017-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CH, CL, CN, DE, EC, ES, FR, GB, JP, NL, NO, NZ, QA, RU, TW |
| Quantity | 154 systems |
| Reason classes | software |
| Model numbers | 25100-05, 25100-06 |
Product
Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media.
Reason for recall
The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) When loading non-square pixel image data with PDM 2.0, the data set is not correctly transferred and displayed in the corresponding Brainlab navigation or planning software. When a data set is loaded, the pixels of the data set are sorted in order to
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-2134-2014. 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.