Philips Healthcare recalls Philips Healthcare DuraDiagnost stationary X-ray system

Recall date

November 10, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1696-2016

FDA classification

Class II

Brand / firm

Philips Healthcare

Sold / distributed

USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.

Why it was recalled

The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Healthcare DuraDiagnost stationary X-ray system