AGFA DX-D 100 Mobile X-Ray System Recalled for Unintended Movement

Plain-English summary

AGFA Healthcare Corp. is recalling 233 units of the AGFA DX-D 100 mobile digital radiography x-ray system. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-1745-2015.

The recall is due to a safety hazard where sporadic unintended movements of the unit may occur. These movements are caused by an electrostatic discharge from the unit to the ground. The affected units were distributed in the United States to the states of AL, CA, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, SC, TN, TX, VA, WV, WI, and WY.

Healthcare facilities and users should identify their equipment by checking the specific serial codes listed in the official recall documentation. Users should contact AGFA Healthcare Corp. for instructions on how to resolve the issue.

The recalled product

Product

AGFA DX-D 100 is a mobile digital radiography x-ray system

Manufacturer

AGFA Healthcare Corp.

Category

Medical Device — Imaging Equipment

Hazard

• unintended-movement
• electrostatic-discharge

Affected units

233

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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