Philips Essenta DR X-ray System C-arm Casting Recall
Philips is recalling 424 Essenta DR stationary X-ray systems because the C-arm casting may loosen and fall.
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 involves a risk-of-harm product (falling heavy machinery component) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Philips Medical Systems, Inc. is recalling 424 units of the Essenta DR stationary X-ray system, model 712070. The recall was initiated because the C-arm casting on the device may loosen and fall.
The affected units were distributed worldwide, including the United States (nationwide), Puerto Rico, and numerous international countries. The Essenta DR is a multifunctional stationary X-ray system designed for radiographic examination of recumbent, standing, or seated patients.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. Users should be aware of the potential for the C-arm casting to detach from the unit.
The recalled product
- Product
- Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for…
- Manufacturer
- Philips Medical Systems, Inc.
- Hazard
- Affected units
- 424
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)
- All Essenta DR x-ray Systems
Distribution
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