Philips Patient Information Center iX Software Malfunction Recall
Philips North America is recalling 7,359 Patient Information Center iX units due to a software malfunction that may cause the system to freeze and become unresponsive.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Philips North America is recalling 7,359 units of the Philips Patient Information Center iX (REF:866389). The recall covers all PIC iX software versions 4.0 through 4.5, identified by UDI (01)00884838127067.
The recall is due to a software malfunction that may cause the patient information system to freeze and become unresponsive. The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries.
Healthcare facilities and consumers should contact Philips North America for further instructions on how to address the software malfunction.
The recalled product
- Product
- Philips Patient Information Center iX REF:866389
- Manufacturer
- Philips North America
- Affected units
- 7,359
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All PIC iX software versions 4.0-4.5/UDI: (01)00884838127067
Distribution
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