PlainRecalls
FDA Devices Moderate Class II Ongoing

DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126

Reported: October 9, 2024 Initiated: February 15, 2024 #Z-3312-2024

Product Description

DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126

Reason for Recall

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.

Details

Recalling Firm
Philips North America Llc
Units Affected
555 units
Distribution
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.
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126. Recalled by Philips North America Llc. Units affected: 555 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 9, 2024. Severity: Moderate. Recall number: Z-3312-2024.