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Open, Classified

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

FDA Recall Z-3312-2024 · Posted 2024-09-30

Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2024-02-15
Product Quantity555 units

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.

Firm Action

Philips North America issued Important Product Information letter CR# 2023-CC-HPM-044, dated 2/15/24 to US consignees. Philips Market Organizations distribute the letters outside of the U.S. Letter states reason for recall, health risk and action to take: Actions that should be taken by the customer / user in order to prevent risks for patients or users 1) Please be aware of the alarms that remain active even though there is an indicator that alarm has been silenced. 2) Look for the water effect on the screen edges, if these exist, take the device out of service and arrange for alternative monitoring device to be used. This notice should be passed on to all those who need to be aware within your organization or to any organization where affected devices have been transferred. 5. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will replace the malfunctioning DIVA 24 Inch Widescreen LCD Touch Display. If you need any further information or support concerning this issue, please contact your local Philips representative.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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