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.
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: 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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