Recall StatusOpen, Classified
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.
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.