FDA-Device2016-07-06Class II
Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
Philips Medical Systems (Cleveland) Inc
Hazard
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.
Sold states
Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
Affected count
10 units
Manufactured in
595 Miner Rd, Cleveland, OH, United States
Products
Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2113-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief