CLASS II Device recall · Reported 29 Mar 2017 · FDA Enforcement Report
Brilliance BigBore Oncology CT recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to, distributed in 22 states. The recall was initiated on 23 Feb 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1492-2017
- FDA event ID
- 76683
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2017
- FDA classified
- 20 Mar 2017
- Reported
- 29 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 23 Feb 2017 | Recall initiated by company | |
| 20 Mar 2017 | Classified by FDA | +25 days |
| 29 Mar 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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%).
Product as listed by the FDA
Brilliance BigBore Oncology CT - 728243 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.
Where it was distributed
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.
ArkansasCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMissouriNorth CarolinaNebraskaNew JerseyNew MexicoNew YorkOhio
Questions about this recall
Why was it recalled?
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%).
Which lots are affected?
System Serial Number - 76002, 76008, 76010, 76011, 76016, 76020, 76021, 76022, 76023, 76024, 76025
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 76683| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Brilliance BigBore Radiology CT recalled by Philips Medical Systems | Philips Medical Systems (Cleveland) | Device Malfunction | 22 states |
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