Philips URODiagnost Eleva X-ray System Recalled for Missing Locking Plate
Philips North America, LLC is recalling URODiagnost Eleva X-ray systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves unexpected mechanical movement that poses a risk of harm to patients or staff, although no specific injuries are reported in the source text.
Plain-English summary
Philips North America, LLC is recalling the URODiagnost Eleva X-ray system, identified by product codes 708026, 708027, and 708028. The recall is due to a potential defect where the locking plate may be missing from the system.
The absence of the locking plate may result in unexpected stand or table tilt movement that cannot be stopped by the user. The affected units were distributed domestically in the United States and internationally worldwide.
Healthcare facilities and users of the affected URODiagnost Eleva systems should contact Philips North America, LLC for instructions on how to resolve the issue. The recall number is Z-1056-2019.
The recalled product
- Product
- URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include…
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — X-ray System
- Affected units
- 1,969
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Philips North America, LLC 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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Similar recalls
- SeverePhilips OmniDiagnost-Eleva X-ray System Recalled Due to Table Rotation Hazard
FDA (Devices) · 2018-07-04
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