The Recall Desk
ModerateFDA (Devices)·Z-2682-2016·Announced 2016-09-07

Philips DuraDiagnost X-ray system recalled for missing labels and volume controls

Philips is recalling 15 DuraDiagnost stationary X-ray systems because the monitor allows users to mute the exposure beep and the tabletop is missing required safety labels.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall involves missing safety labels and a volume control issue that violates regulations, but no injuries or illnesses are reported, fitting the criteria for a moderate severity recall.

Plain-English summary

Philips Electronics North America Corporation is recalling 15 units of the Philips DuraDiagnost stationary X-ray system. The recall is due to two regulatory violations: the monitor buttons allow the user to turn the volume setting down to 0, which prevents the required beep from being heard at the conclusion of an exposure, and the Height-Adjustable Tabletop is missing required labels.

The affected units were distributed in the United States to the states of Maine, Nebraska, Oregon, California, Texas, North Carolina, Washington, and Ohio. The specific serial numbers for the recalled units are 140054, 140059, 150013, 150014, 150039, 150041, 150042, 150052, 150053, 150055, 150056, 150059, 150061, 150091, and 150093.

Healthcare facilities should check their inventory for these serial numbers and contact Philips Electronics North America Corporation for instructions on how to resolve the labeling and volume control issues.

The recalled product

Product
Philips DuraDiagnost stationary X-ray system
Affected units
15

Distribution

Distributed in 8 states:

Same manufacturer · Philips Electronics North America Corporation

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