The Recall Desk
HighFDA (Devices)·Z-1052-2019·Announced 2019-04-03

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.

What this means for you

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. This
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.

See all 5 products in this recall →