Philips MultiDiagnost Eleva X-ray System Recalled for 3D Reconstruction Failure
Philips Healthcare Inc. is recalling 41 units of the MultiDiagnost Eleva X-ray system because the 3D reconstruction feature may fail to start during rotational angiography.
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 defect is a functional failure of a software feature (3D reconstruction) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Healthcare Inc. is recalling 41 units of the Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD) Model 708034 X-ray system. The recall is due to a software defect where the 3D reconstruction process does not always start, even when all images have been acquired during a 3 Dimensional Rotational Angiography (3DRA) procedure.
The affected units were distributed worldwide, including in the United States (nationwide, with specific mentions of CA, CT, MI, MN, NC, NY, and VA) and in various international locations such as Belgium, Columbia, Czech Republic, Denmark, France, Germany, Italy, Latvia, Luxembourg, Netherlands, Russian Fed., Spain, Sweden, Switzerland, Thailand, and the United Kingdom. Specific US and worldwide serial numbers are listed in the official recall documentation.
Healthcare facilities should contact Philips Healthcare Inc. for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
- Manufacturer
- Philips Healthcare Inc.
- Category
- Medical Device — X-ray System
- Hazard
- Affected units
- 41
Distribution
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