FDA-Device2015-03-18Class II

Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211

Philips Medical Systems, Inc.
Hazard

Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float.

Sold states
Worldwide Distribution. Argentina, Australia, Burkina-Faso, Chile, China, Colombia, Ecuador, France, Germany, Hungary, Indonesia, Iraq (NL), Kuwait, Libya, Macedonia, Malaysia, Mayotte, Poland, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey, United Kingdom, and Uzbekistan.
Affected count
71 units
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1251-2015

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