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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 555
Distribution
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