Reported Jul 6, 2016 · Terminated
Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
- Lot codes and dates
- 901510
- Amount recalled
- 1 unit
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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