The Recall Desk
HighFDA (Devices)·Z-3312-2024·Announced 2024-10-09

Medical Display Unit Recalled for Unintended Touch Input During Patient Monitoring

Philips DIVA 24-inch touch display may generate unintended touch inputs, risking erroneous acknowledgement of patient alarms and delayed detection of patient condition changes. No injuries have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—unintended touch inputs that could delay alarm detection—but the source characterizes the risk as 'unlikely.' Per the rubric, a product with risk-of-harm where injury has not been reported scores a 3 (High).

Plain-English summary

Philips North America LLC is recalling the DIVA 24 Inch Widescreen LCD Touch Display (Model RGD2461AMI, Philips Part #866126) used with the Philips PIC iX system central monitoring system. Approximately 555 units have been distributed. The device can generate touch inputs without user interaction. This malfunction may cause erroneous acknowledgement of patient alarms, potentially delaying detection of patient condition changes that triggered the alarm. While the manufacturer describes this as unlikely, it could potentially result in patient harm. No illnesses or injuries have been reported to date.

The device has been distributed worldwide. In the United States, affected states include California, Illinois, Maine, North Carolina, New Jersey, New Mexico, New York, Ohio, Virginia, and Washington. International distribution encompasses Australia, Austria, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, and the United Kingdom.

Healthcare facilities that have received this device should contact Philips North America LLC regarding this recall.

The recalled product

Product
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
Manufacturer
Philips North America Llc
Hazard
  • ghost-touch
  • alarm-misacknowledge

Distribution

Distributed nationwide across the United States.