Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is…
Medical device recall Z-0218-2016. Published in FDA’s Enforcement Report on Nov 11, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 11, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 897 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
897, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,994 characters
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…
FDA’s list runs to 3,439 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 21, 2015.
- FDA classified it on Nov 5, 2015.
- FDA’s Enforcement Report published it on Nov 11, 2015.
- FDA terminated it on Apr 24, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Brainlab AG, of Feldkirchen, Germany.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,439 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.