Philips Essenta DR X-Ray System Recalled Due to Potential C-Arm Fall
Philips Healthcare Inc. is recalling seven Essenta DR X-ray systems because the C-arm may fall. The recall covers units distributed in the US and several international countries.
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 (C-arm may fall) which poses a risk of significant injury, meeting the criteria for a Severe (Score 4) classification under the rubric for structural defects or significant injury reports.
Plain-English summary
Philips Healthcare Inc. is recalling seven units of the Philips Essenta DR, X-Ray System, Diagnostic, general-purpose (Model 712070). The recall is being conducted because the C-arm component of the system may fall. The Essenta DR is a multifunctional stationary X-ray system designed for radiographic examination of recumbent, standing, or seated patients.
The affected units were distributed worldwide, including in the United States (California, North Carolina, and Tennessee) and in China, Germany, and Hungary. The specific serial numbers for the recalled units are SN09000006, SN09000007, SN10000033, SN10000014, SN100000654, SN08000092, and SN08000050.
Healthcare facilities and users should contact Philips Healthcare Inc. for instructions on how to address this issue. The source text does not specify the exact remediation steps or the date of the recall.
The recalled product
- Product
- Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are…
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 7
Distribution
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