The Recall Desk
SevereFDA (Devices)·Z-1607-2018·Announced 2018-05-09

Philips MD-Eleva Medical Imaging System Recalled for Tilt Actuator Failure

Philips is recalling 199 MD-Eleva imaging systems because a tilt actuator may break, causing the 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 causes uncontrollable high-speed rotation, posing a significant risk of injury to patients and staff.

Plain-English summary

Philips Medical Systems Nederlands is recalling 199 units of the Mutlidiagnost-Eleva with Flat Detector (Model 708037). These multifunctional imaging systems are used for general radiography, fluoroscopy, and angiography on human patients.

The recall is due to a mechanical defect where the fixation of the upper and lower tilt actuator may 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. Healthcare facilities should contact the manufacturer for instructions on how to address this defect.

The recalled product

Product
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 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
199

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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