Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ingenuity Core Recalled by Philips Medical Systems (Cleveland) Inc Due to Supplier design change contributed to a thinner plastic...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems (Cleveland) Inc directly.
Affected Products
Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
Quantity: 1 unit
Why Was This 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 causing injury to patients, operators, by-standers and service personnel.
Where Was This Sold?
Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
About Philips Medical Systems (Cleveland) Inc
Philips Medical Systems (Cleveland) Inc has 313 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report