Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient ...
FDA Device Recall #Z-0218-2016 — Class II — September 21, 2015
Recall Summary
| Recall Number | Z-0218-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 21, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Brainlab AG |
| Location | Feldkirchen, N/A |
| Product Type | Devices |
| Quantity | 897 |
Product Description
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.
Lot / Code Information
Potentially affected are Patient Data Manager versions 2.0.0, 2.0.1, 2.0.2, 2.0.3, 2.1.0. Serial numbers/lot numbers are not applicable for a software version. Model/catalogue numbers: Main model/catalogue numbers: 25121-01 PATIENT DATA MANAGER 2.0.0 LICENSE ONLY 25100-05 PATIENT DATA MANAGER 2.0.1 LICENSE ONLY 25100-06 PATIENT DATA MANAGER 2.0.2 LICENSE ONLY 25100-07 PATIENT DATA MANAGER 2.0.3 LICENSE ONLY 25100-08 Further the above listed main-articles are incorporated into the following model/catalogue numbers: 15600 MULTI-TOUCH INFORMATION GATEWAY 15610 IN-WALL MULTI-TOUCH INFORMATION GATEWAY 15700 CURVE CEILING-MOUNTED DUAL DISPLAY 15705 CURVE CEILING-MOUNTED SINGLE DISPLAY 15709-10 CURVE CM COMPUTER UNIT 18070 KICK NAVIGATION STATION 18071 KICK MONITOR CART 18071-19 KICK MONITOR CART BASE (WITH OS) 18073-17 KICK MCU (WITH OS) 18077 KICK UPGRADE NAVIGATION STATION 18078 KICK NAVIGATION STATION (REFURB. CAMERA) 18080 KICK NAVIGATION STATION 18080-01 KICK NAVIGATION STATION BRAZIL 18080-02 KICK NAVIGATION STATION CHINA 18081 KICK DPS MONITOR CART 18081-19 KICK DPS MONITOR CART BASE (WITH OS) 18083-17 KICK DPS MCU (WITH OS) 18090 KICK EM NAVIGATION STATION 19900 CURVE DUAL DISPLAY NAVIGATION STATION 19900-04B MONITOR CART-CURVE DUAL DISPL. SPAREPART 19900-04C MONITOR CART-CURVE DUAL DISPL. SPAREPART 19905 CURVE SINGLE DISPLAY NAVIGATION STATION 19905-04B MONITOR CART-CURVE SINGLE DISP SPAREPART 22216 CRANIAL NAVIGATION SW 3.0 22217 ENT NAVIGATION SW 3.0 22241 NAVIGATION SW ENT EM 1.0 22241-01 NAVIGATION SW ENT EM 1.0 - FOR BENELUX 22244 NAV SW ENT EM 1.0 ADD-ON FOR OPT NAV 22245 NAV SW ENT OPTICAL ADDON FOR ENT EM NAV 22267 SPINE & TRAUMA 3D (VER. 2.1) 25100C PATIENT BROWSER AND CONTENT MANAGER 25100D PATIENT BROWSER AND CONTENT MANAGER 25110 BRAINLAB SESSION SHARING NURSE STATION 25121 PATIENT BROWSER AND CONTENT MANAGER 26201-12A ORIGIN DATA MANAGEMENT SUBSCRIPTION 26201-36A ORIGIN DATA MANAGEMENT SUBSCRIPTION 26201-60A ORIGIN DATA MANAGEMENT SUBSCRIPTION 26201A ORIGIN DATA MANAGEMENT SUBSCRIPTION 26243A UPGRADE TO ORIGIN DATA MANAGEMENT 26269-12A ORIGIN DATA MANAGEMENT SUBSCRIPTION FOC 26269-36A ORIGIN DATA MANAGEMENT SUBSCRIPTION FOC 26269-60A ORIGIN DATA MANAGEMENT SUBSCRIPTION FOC 26269A ORIGIN DATA MANAGEMENT SUBSCRIPTION FOC 26282 UPGRADE TO ORIGIN DATA MANAGEMENT FOC 26290 ELEMENTS PLANNING SUITE FOR NAVIGATION 26291 ELEMENTS PLANNING SUITE FOR BUZZ 27001 NAVIGATION SOFTWARE KNEE 3 27003 NAVIGATION SOFTWARE KNEE 3 BASE SOFTWARE 27004 UPG NAVIGATION SOFTWARE KNEE 3 BASE SW 27006 UPG NAVIGATION SOFTWARE KNEE 3 BASE SW 27007 NAVIGATION SOFTWARE KNEE3 UNIVERSAL 30038A ORIGIN DATA MANAGEMENT 30039 ORIGIN DATA MANAGEMENT ORTHO 70346 UPD PATIENT BROWSER&CONTENT MANAGER 2.X 70349 UPD PACKAGE PDM 1.X TO 2.X INCL ELEMENTS 71201 UPG TO NAV SW CRAN 3.0 FROM CRAN 2.X 71202 UPG TO CRANIAL NAV SW 3.0 FROM ANY PREV 71202 UPG TO CRANIAL NAV SW 3.0 FROM ANY PREV 71203 UPG TO NAV SW ENT 3.0 FROM ENT 2.X 71204 UPG TO ENT NAV SW 3.0 FROM ANY PREV E15600 MULTI-TOUCH INFORMATION GATEWAY E15709-10 CURVE CM COMPUTER UNIT E18073-17 KICK MCU (WITH OS) E19900 CURVE DUAL DISPLAY NAVIGATION STATION E19900-04B MONITOR CART-CURVE DUAL DISPL. SPAREPART E19900-04C MONITOR CART-CURVE DUAL DISPL. SPAREPART E19900-05 MONITOR CART-CURVE BYPASS 2 DISP SPARE E19905 CURVE SINGLE DISPLAY NAVIGATION STATION E19905-04B MONITOR CART-CURVE SINGLE DISP SPAREPART E19905-05 MONITOR CART-CURVE BYPASS 1 DISP SPARE
Other Recalls from Brainlab AG
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1392-2025 | Class II | Origin Data Management software versions 3.1.0,... | Feb 10, 2025 |
| Z-1292-2023 | Class II | Cirq Arm System 2.0 | Mar 2, 2023 |
| Z-1259-2023 | Class II | Brainlab ExacTrac Dynamic software, Medical Cha... | Feb 14, 2023 |
| Z-0733-2022 | Class II | ExacTrac Dynamic software model numbers: 209... | Feb 25, 2022 |
| Z-1846-2021 | Class II | ExacTrac Dynamic software, Model 20910-01B ETD ... | May 14, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.