# FDA recall Z-3312-2024

> **Philips North America Llc** · Class II · device recall initiated 2024-02-15.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-3312-2024
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-15
- **Report date:** 2024-10-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3312-2024

## Citation

> AI Analytics. FDA recall Z-3312-2024. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-3312-2024. Source: US FDA. Licensed CC0.

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