The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1696-2016·Announced 2016-06-15

Philips DuraDiagnost X-ray System Recalled for Image Acquisition Failure

Philips Healthcare is recalling five DuraDiagnost stationary X-ray systems because the detector may incorrectly signal readiness, causing failed image acquisitions.

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 is classified as FDA Class II, but the source text explicitly states no injuries or illnesses have been reported. The hazard is a functional failure leading to diagnostic delay rather than direct physical harm, fitting the criteria for a moderate severity score.

Plain-English summary

Philips Healthcare is recalling five units of the DuraDiagnost stationary X-ray system. The recall affects software versions 4.0.2, 4.0.3, and 4.0.4, which are being updated to version 4.0.5. The devices were distributed nationwide to the states of Ohio, California, Washington, and Nebraska.

The recall was initiated because the detector may signal that it is ready for acquisition when it is actually not. This malfunction results in the failure to properly acquire the X-ray image. The source text does not report any injuries, illnesses, or deaths associated with this defect.

Healthcare facilities should contact Philips Healthcare for instructions on updating the software to version 4.0.5 to resolve the issue.

The recalled product

Product
Philips Healthcare DuraDiagnost stationary X-ray system
Manufacturer
Philips Healthcare
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
5

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 (3)

  • software version - 4.0.2
  • 4.0.3
  • 4.0.4 into 4.0.5

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Philips Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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