Recall Z-3312-2024 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America Llc
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
| Date | Sep 30, 2024 (initiated Feb 15, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153702 | M3290B Philips IntelliVue Information Center iX Philips Medical Systems, Jun 13, 2016 |