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.
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 2/5 (Moderate).
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
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 15
Distribution
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