Philips MultiDiagnost-Eleva Imaging System Recalled for Missing Locking Plate
Philips is recalling MultiDiagnost-Eleva imaging systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where unexpected movement could cause injury, but no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips North America, LLC is recalling the MultiDiagnost-Eleva imaging system, product codes 708032 and 708036. The recall involves 1,969 units that were distributed domestically in the United States and internationally worldwide. The system is used for various imaging procedures, including fluoroscopy, radiography, and angiography.
The recall is due to a potential missing locking plate in the system. This defect may result in unexpected stand or table tilt movement that cannot be stopped by the user. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities should contact Philips North America, LLC for instructions on how to resolve the issue. Consumers and patients should not use the affected equipment until it has been inspected and repaired by the manufacturer.
The recalled product
- Product
- MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients.…
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Imaging System
- Hazard
- Affected units
- 1,969
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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.
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