Philips URODiagnost Imaging System Recalled Due to Uncontrolled Table Rotation
Philips Medical Systems is recalling 20 URODiagnost 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 structural defect in a medical device that results in uncontrolled, high-speed movement which cannot be stopped by the user, posing a significant risk of injury, which aligns with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Philips Medical Systems Nederlands is recalling 20 units of the 708033 URODiagnost multifunctional universal imaging application system. The recall is due to a defect where the fixation of the upper and lower tilt actuator of the MD-Eleva system 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 units were distributed worldwide, including in the United States and numerous other countries. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- 708033 URODiagnost 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
- 20
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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