FDA-Device2012-10-03Class II

Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.

Philips Healthcare Inc.
Hazard

The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down

Sold states
Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, Chile, Finland, France, Germany, Hungary. Italy, Japan, Latvia, Netherlands, New Zealand. Oman, South Korea, Switzerland and United Kingdom.
Affected count
93 Units
Manufactured in
3000 Minuteman Road, N/A, Andover, MA, United States
Products
Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2465-2012

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