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Recall Observatory FDA recall evidence

Device product

Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.

Z-2111-2016

June 21, 2016

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 74511
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-2111-2016

Official wording

Reason: 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.

Code information: 921216

Distribution pattern: Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.