Agency classClass IIOur severity:High FDA (Devices)·Z-1745-2015·Announced 2015-06-17

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

AGFA Healthcare Corp. is recalling 233 mobile digital radiography x-ray systems due to a risk of sporadic unintended movements caused by electrostatic discharge.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves unintended movement of a heavy medical device, which presents a risk of harm even though no specific injuries are reported in the source text.

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.

Lot numbers (20)

A5410000053
A5410000054
A5411000439
A5411000446
A5411000447
A5411000448
A5410000067
A5410000068
A5410000069
A5410000070
A5410000072
A5410000073
A5411000420
A5410000100
A5410000107
A5410000114
A5410000115
A5410000116
A5410000117
A5410000132

Distribution

Distributed in 29 states:

Same manufacturer · AGFA Healthcare Corp.

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Same hazard · unintended movement