Reported Dec 12, 2018 · Terminated
Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce…
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 16 Slice (Air)
- Model 728246 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 Number260038_ 260039_ 4043* 4702_08 50023_ 50057A 50134_ 5087-1 5094_DEL 5238A 5389A 5666-OLD 5916-OLD 6140A 6140-OLD 6244/13897/79922 6264_ 6762_ CT5781/EBW11689 ESPREVENTIVOSCT IBA_5104 IBA_5134 IBA_5162 SN50187 SN5682 SN5836 SN6620 STOR_DEMO_43574835 SZ50219 SZ50220 XXX_5870
2,269 of 2,269 codes
64615543007301030113012301330143015301630173018302030233027302930303031303830403041304330473050305730593070307230823085309030953103311031113117312331273135314131493150316031613162316331643170317931853189319132023205321632173219322432273244
- 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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