Medical device recalls Moderate risk

Philips Electronics North America Corporation recalls Philips DigitalDiagnost 3.1.x X-Ray System

Recall date
May 11, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2154-2017
FDA classification
Class II
Brand / firm
Philips Electronics North America Corporation
Sold / distributed
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

Why it was recalled

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.

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 DigitalDiagnost 3.1.x X-Ray System

Get recall alerts

Free email alert whenever Philips Electronics North America Corporation has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Philips Electronics North America Corporation