Reported Dec 12, 2018 · Terminated
Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images…
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Brilliance 40
- Model 728235 Product UsageComputed 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
- Lot codes and dates
- System Serial Number728235_342-1618 90192 90213
374 of 374 codes
93815131520401240229031903290349036903990429046904790509053905590579060906190639076907890799082908390849085908890909091909490959097910091019102910391099110911191129113911491159116911991229123912491259126912791289129913091319132913391369141
- System Serial Number
- Amount recalled
- 6,343 units in total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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