FDA-Device2024-10-09Class II
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
Philips North America Llc
Hazard
If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a patient condition which prompted the alarm to generate. Although unlikely, this could potentially result in a patient harm.
Sold states
Worldwide - US Nationwide distribution in the states of CA, IL, ME, NC, NJ, NM, NY, OH, VA, WA and the countries of Australia, Austria, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, United Kingdom.
Affected count
555 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3312-2024Don't want to check this manually?
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