{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Feldkirchen",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72236",
      "recalling_firm": "Brainlab AG",
      "address_1": "Kapellenstr. 12",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "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.",
      "recall_number": "Z-0218-2016",
      "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.",
      "product_quantity": "897",
      "reason_for_recall": "Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.",
      "recall_initiation_date": "20150921",
      "center_classification_date": "20151105",
      "termination_date": "20170424",
      "report_date": "20151111",
      "code_info": "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 \u0013 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"
    }
  ]
}