Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce…
Medical device recall Z-1493-2017. Published in FDA’s Enforcement Report on Mar 29, 2017.
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 Mar 29, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 22 states named in where it went
- 67 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?
Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
67, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
System Serial Number - 76001, 76005, 76007, 76009, 76013, 76014, 76017, 76018, 76019, System Serial Number - Unique Device Identifier 76058 (01)00884838059450(21)76058 76033 (01)00884838059450(21)76033 76048 (01)00884838059450(21)76048…
Every code shown here, 2,000 characters
System Serial Number - 76001, 76005, 76007, 76009, 76013, 76014, 76017, 76018, 76019, System Serial Number - Unique Device Identifier 76058 (01)00884838059450(21)76058 76033 (01)00884838059450(21)76033 76048 (01)00884838059450(21)76048 76059 (01)00884838059450(21)76059 76015 (01)00884838059450(21)76015 76063 (01)00884838059450(21)76063 76066 (01)00884838059450(21)76066 76049 (01)00884838059450(21)76049 76040 (01)00884838059450(21)76040 76032 (01)00884838059450(21)76032 76061 (01)00884838059450(21)76061 76031 (01)00884838059450(21)76031 76006 (01)00884838059450(21)76006 76041 (01)00884838059450(21)76041 76035 (01)00884838059450(21)76035 76038 (01)00884838059450(21)76038 76065 (01)00884838059450(21)76065 76064 (01)00884838059450(21)76064 76053 (01)00884838059450(21)76053 76050 (01)00884838059450(21)76050 76060 (01)00884838059450(21)76060 76036 (01)00884838059450(21)76036 76056 (01)00884838059450(21)76056 76055 (01)00884838059450(21)76055 76037 (01)00884838059450(21)76037 76051 (01)00884838059450(21)76051 76044 (01)00884838059450(21)76044 76039 (01)00884838059450(21)76039 76012 (01)00884838059450(21)76012 76026 (01)00884838059450(21)76026 760016 (01)00884838059450(21)760016 760001 (01)00884838059450(21)760001 760005 (01)00884838059450(21)760005 760004 (01)00884838059450(21)760004 760003 (01)00884838059450(21)760003 760007 (01)00884838059450(21)760007 76072 (01)00884838059450(21)76072 76062 (01)00884838059450(21)76062 76043 (01)00884838059450(21)76043 760013 (01)00884838059450(21)760013 760014 (01)00884838059450(21)760014 76029 (01)00884838059450(21)76029 760010 (01)00884838059450(21)760010 76027 (01)00884838059450(21)76027 760011 (01)00884838059450(21)760011 760009 (01)00884838059450(21)760009 760006 (01)00884838059450(21)760006 76045 (01)00884838059450(21)76045 76054 (01)00884838059450(21)76054 76069 (01)00884838059450(21)76069 76034 (01)00884838059450(21)76034 76030 (01)00884838059450(21)76030 76047 (01)00884838059450(21)76047 76057 (01)00884838059450(21)76057 76028…
FDA’s list runs to 2,133 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 to AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, TX & WI; Internationally to the following countries: Australia, Austria, Canada, China, Czech Republic, Germany, India, Israel, Jordan, Korea, Mexico, New Cldonia, Romania, Russian Federation, Turkey, & United Kingdom.
The states and territories these words name
22 states and territories.
Every one of them
- Arkansas
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Missouri
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- New York
- Ohio
- Texas
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Feb 23, 2017.
- FDA classified it on Mar 20, 2017.
- FDA’s Enforcement Report published it on Mar 29, 2017.
- FDA terminated it on Feb 26, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Medical Systems (Cleveland) Inc, of Cleveland, OH.
- 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 2,133 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.