Philips MD-Eleva Imaging System Recalled for Uncontrolled Table Rotation
Philips is recalling 206 MD-Eleva imaging systems because the tilt actuator fixation 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 mechanical defect in a medical device that causes uncontrollable high-speed rotation, posing a significant risk of injury to patients or staff, which aligns with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Philips Medical Systems Nederlands is recalling 206 units of the Mutlidiagnost-Eleva with Flat Detector 708034 imaging system. The recall is due to a defect where the fixation of the upper and lower tilt actuator might break off.
If this failure occurs, the table will start to rotate from 0 to +90 or -90 degrees with high speed. The source text states that this rotating movement cannot be stopped by the user. The affected systems are distributed worldwide, including in the United States and numerous other countries.
Healthcare facilities should contact Philips Medical Systems Nederlands for instructions on how to address this defect. The recall number is Z-1606-2018.
The recalled product
- Product
- Mutlidiagnost-Eleva with Flat Detector 708034 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
- 206
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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