Severe FDA (Devices)·Z-2207-2012·Announced 2012-08-22

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.

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 (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 motorize
Manufacturer: Philips Healthcare Inc.
Category: Medical Device — Diagnostic Imaging
Hazard: falling-object
structural-defect
Affected units: 7

Distribution

Distributed in 3 states:

Same manufacturer · Philips Healthcare Inc.

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Same hazard · falling object