DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD246
FDA device recall Z-3312-2024 · posted 2024-09-30 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- MHX
- Quantity 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,
- Date initiated
- 2024-02-15
- Date posted
- 2024-09-30
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| M3290B Philips IntelliVue Information Center iX (K153702) | Philips Medical Systems | 2016-06-13 |