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Recall Observatory FDA recall evidence

Device product

Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.

Z-2114-2016

June 21, 2016

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 74511
Status
Terminated
Classification
Class II
Quantity
14 units
Official record key
device-enforcement:Z-2114-2016

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 causing injury to patients, operators, by-standers and service personnel.

Code information: 901469, 901479, 901487, 901491, 901497, 901502, 901508, 901515, 901517, 901518, 901520, 901530, 901533, 921223

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 causing injury to patients, operators, by-standers and service personnel.