CLASS II Device recall · Reported 6 Jul 2016 · FDA Enforcement Report
Brilliance CT Big Bore Oncology recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling Brilliance CT Big Bore Oncology. The recall was initiated on 21 Jun 2016 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-2111-2016
- FDA event ID
- 74511
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2016
- FDA classified
- 30 Jun 2016
- Reported
- 6 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 21 Jun 2016 | Recall initiated by company | |
| 30 Jun 2016 | Classified by FDA | +9 days |
| 6 Jul 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack and cause injury to patients, operators, by standers or service personnel.
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 CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
Where it was distributed
Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
Questions about this recall
Why was it recalled?
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack and cause injury to patients, operators, by standers or service personnel.
Which lots are affected?
921216
Where was it sold?
Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and 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
4 other products · FDA event 74511This product is part of a recall event; the main page for the event is Brilliance iCT recalled by Philips Medical Systems.
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