FDA-Device2014-10-15Class II
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Philips Medical Systems, Inc.
Hazard
Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
Sold states
US distribution to FL
Affected count
one system
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0022-2015Don't want to check this manually?
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