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Philips Medical Systems is recalling 19 Easy Diagnost Eleva devices because they were delivered with outdated application software.
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, 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 The recall was initiated because the delivered application software was an outdated version for the model of equipment.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.
- 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
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