CLASS II Device recall · Reported 12 Dec 2018 · FDA Enforcement Report
Brilliance 10 Slice (Air) recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling Brilliance 10 Slice (Air), distributed nationwide in the US. The recall was initiated on 18 Oct 2018 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-0547-2019
- FDA event ID
- 81569
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Oct 2018
- FDA classified
- 30 Nov 2018
- Reported
- 12 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Imaging Equipment
Timeline
| 18 Oct 2018 | Recall initiated by company | |
| 30 Nov 2018 | Classified by FDA | +43 days |
| 12 Dec 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Brilliance 10 Slice (Air), Model 728251 Product Usage: 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
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it 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
Which lots are affected?
System Serial Number: 2598 3008 3098 4001 4002 4003 4005 4006 4007 4008 4009 4010 4011 4012 4014 4015 4016 4020 4021 4022 4023 4026 4027 4028 4029 4030 4031 4032 4033 4034 4035 4039 4040 4044 4045 4047 4048 4049 4050 4052 4053 4054 4056 4058 4059 4061 4062 4063 4064 4065 4066 4067 30099 40004 40005 40006 40007 40008 40009 40010 40011 40012 40014 40015 40016 40018 40019 40020 40021 40023 40025 40028 40029 40031 40032 40034 62986554 4008/6086 4039/7128 728251_859-1766
Where was it sold?
US Nationwide Distribution
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
5 other products · FDA event 81569This product is part of a recall event; the main page for the event is Brilliance 6 Slice (Air) recalled by Philips Medical Systems.
More recalls from Philips Medical Systems (Cleveland)
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|---|---|---|---|---|---|
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| Device | CLASS II | Pinnacle3 Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Other | 21 states |
| Device | CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
| Device | CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |