FDA recall Z-2154-2017

Product

Philips DigitalDiagnost 3.1.x X-Ray System

Reason for recall

During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.

Distribution

USA(nationwide) Distribution to the states of : AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA and WI

Key facts

Status

Terminated

Initiation date

2017-05-11

Report date

2017-06-21

Termination date

2018-07-10

Voluntary/Mandated

FDA Mandated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2154-2017