The Recall Desk
ModerateFDA (Devices)·Z-0431-2014·Announced 2013-12-11

Philips Easy Diagnost Eleva Fluoroscopic Software Recall

Philips Medical Systems is recalling 19 Easy Diagnost Eleva devices because they were delivered with outdated application software.

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 is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source text identifies a software version mismatch without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Philips Medical Systems, Inc. is recalling 19 Easy Diagnost Eleva Universal Fluoroscopic applications. The recall was initiated because the delivered application software was an outdated version for the model of equipment.

The affected devices were distributed nationwide, including in Minnesota, New Hampshire, Delaware, Oregon, Massachusetts, Texas, Ohio, Florida, California, Washington, and South Carolina. The specific codes associated with the recall are 706050, 706083, and 706088.

Healthcare facilities should contact Philips Medical Systems to verify the software version and arrange for the necessary updates or replacements.

The recalled product

Product
Easy Diagnost Eleva Universal Fluoroscopic applications
Manufacturer
Philips Medical Systems, Inc.
Category
Medical Device — Fluoroscopic Equipment
Hazard
Affected units
19

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)

  • 706050
  • 706083
  • 706088

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

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