The Recall Desk
SevereFDA (Devices)·Z-1605-2018·Announced 2018-05-09

Philips MultiDiagnost Eleva Imaging System Recalled for Uncontrolled Table Rotation

Philips is recalling 37 MultiDiagnost Eleva imaging systems because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device that results in uncontrolled, high-speed movement of the patient table, which poses a significant risk of injury.

Plain-English summary

Philips Medical Systems Nederlands is recalling 37 units of the MultiDiagnost Eleva 708036 imaging system. This multifunctional system is used for general radiography, fluoroscopy, angiography, and specialized interventional applications on human patients.

The recall is due to a defect where the fixation of the upper and lower tilt actuator might break off. If this occurs, the patient table will start to rotate from 0 to +90 or -90 degrees at high speed. The source text states that this rotating movement cannot be stopped by the user.

The affected units were distributed worldwide, including in the United States and numerous other countries. The recall notice does not specify specific actions for consumers or healthcare providers beyond the identification of the defect.

The recalled product

Product
MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Affected units
37

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Philips Medical Systems Nederlands 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 7 products in this recall →

Same manufacturer · Philips Medical Systems Nederlands

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