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 is classified as FDA Class II, and the hazard involves unexpected mechanical movement of a medical device that could pose a risk of harm to patients or staff, although no specific injuries are reported in the source text.
Plain-English summary
Philips North America, LLC is recalling the MultiDiagnost Eleva w/ Flat Detector imaging system, including product codes 708034, 708037, and 708038. The recall involves 1,969 units that were distributed domestically in the United States and internationally worldwide.
The recall was initiated because the locking plate may be missing from the system. This defect may result in unexpected stand or table tilt movement that cannot be stopped by the user. The system is used for various medical imaging applications, including fluoroscopy, radiography, and angiography on human patients.
Healthcare facilities and users should contact Philips North America, LLC for instructions on how to resolve the issue. The recall number is Z-1055-2019.
The recalled product
- Product
- MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional…
- Manufacturer
- Philips North America, LLC
- 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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