Philips EasyDiagnost Eleva DRF X-ray System Recalled for Power Supply Defect
Philips is recalling 52 EasyDiagnost Eleva DRF X-ray systems because incorrectly installed thermo switches in the main power supply may cause malfunction.
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 medical device with a functional defect (malfunction) but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America, LLC is recalling 52 units of the EasyDiagnost Eleva DRF, model no. 706050, a general-purpose diagnostic X-ray system. The recall is due to a defect where thermo switches in the main power supply may be incorrectly installed, resulting in a malfunction.
The affected units were distributed worldwide and nationwide in the United States, including in the states of AR, AZ, CA, CT, FL, GA, HI, IL, LA, MA, MD, MI, MS, MT, NC, NY, TN, TX, and in the country of Panama. The recall covers specific serial numbers listed in the agency's documentation.
Healthcare facilities and users should contact Philips North America, LLC for instructions on how to address the defect. The source text does not report any specific injuries or illnesses associated with this malfunction.
The recalled product
- Product
- EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 52
Distribution
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