The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1492-2020·Announced 2020-03-25

Philips UroDiagnost Eleva X-ray System Recalled for Capacitor Failure

Philips is recalling four UroDiagnost Eleva X-ray systems because a capacitor may fail, preventing image acquisition.

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. The hazard involves a functional failure (inability to acquire images) rather than a direct physical injury or death, fitting the criteria for moderate severity.

Plain-English summary

Philips North America, LLC is recalling four units of the UroDiagnost Eleva X-ray system, system code 708033. The recall is due to a potential failure of a capacitor inside the Velara X-ray generator. This failure may occur after a large number of surges in a short period of time.

When the capacitor fails, no image acquisition is possible. The affected units have serial numbers 64 48 2 60. The products were distributed domestically nationwide and internationally worldwide.

Healthcare facilities should contact Philips North America, LLC for instructions on how to resolve the issue. The recall is classified as Class II by the FDA.

The recalled product

Product
UroDiagnost Eleva, system code 708033
Manufacturer
Philips North America, LLC
Category
Medical Device — X-ray System
Hazard
Affected units
4

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 (1)

  • Serial numbers 64 48 2 60

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Philips North America, LLC 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 9 products in this recall →

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