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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Manufacturer
- Philips Medical Systems Nederlands
- Category
- Medical Device — Imaging Systems
- 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.
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