Philips MultiDiagnostic-Eleva Imaging System Recalled Due to Uncontrolled Table Rotation
Philips is recalling the MultiDiagnostic-Eleva imaging system because a broken actuator fixation can cause the patient 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 results in uncontrolled, high-speed movement of the patient table, posing a significant risk of injury to patients and staff.
Plain-English summary
Philips Medical Systems Nederlands is recalling the MultiDiagnostic-Eleva with Flat Detector 708035 imaging system. This multifunctional universal imaging application system is used for general radiography, fluoroscopy, angiography, and specialized interventional applications on human patients.
The recall is issued because the fixation of the upper and lower tilt actuator might break off. If this occurs, the patient table may 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. No specific lot numbers or dates are provided in the source text. Users of this equipment should contact the manufacturer for further instructions on how to address this defect.
The recalled product
- Product
- MultiDiagnostic-Eleva with Flat Detector 708035 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
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Pending
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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