Philips MultiDim Eleva Imaging System Recalled for Uncontrolled Table Rotation
Philips is recalling 184 MultiDim 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 causes uncontrolled, high-speed movement of the patient table, posing a significant risk of injury.
Plain-English summary
Philips Medical Systems Nederlands is recalling 184 units of the MultiDim Eleva 708032 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. 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 Philips for instructions on how to address this defect.
The recalled product
- Product
- MultiDim Eleva 708032 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.
- Manufacturer
- Philips Medical Systems Nederlands
- Category
- Medical Device — Imaging System
- Affected units
- 184
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.
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