Medium RiskFDA Device

Philips Medical Systems (Cleveland) Inc: 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.; 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.; Supplier design change contributed to a thinner plastic which was used as part of the cover o

Agency Publication Date: June 30, 2016

Affected Products

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

921216

Product: Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.

911162

Product: Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.

901475, 901476, 901495, 901505, 901509, 901513, 901529, 901532, 901539, 901541

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

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

Product: Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.

901510

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74511

Status: Resolved

Manufacturer: Philips Medical Systems (Cleveland) Inc

Manufactured In: United States

Units Affected: 5 products (3 units; 1 unit; 10 units; 14 units; 1 unit)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.