Philips PIC iX Essentials Patient Information System Software Recall
Philips North America is recalling 312 units of the PIC iX Essentials patient information system due to a software malfunction that may cause the system to freeze.
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 is classified as FDA Class II and involves a risk-of-harm product (medical device malfunction) where no injuries or illnesses have been reported, meeting the criteria for a High severity score.
Plain-English summary
Philips North America is recalling 312 units of the Philips PIC iX Essentials patient information system (REF:867093). The recall affects all PIC iX software versions 4.0 through 4.5. The product was distributed worldwide, including nationwide in the United States and in numerous international countries.
The recall is being issued due to a software malfunction that may cause the patient information system to freeze and become unresponsive. The source text does not report any specific injuries, illnesses, or deaths associated with this malfunction.
Healthcare facilities and users should contact Philips North America for instructions on how to address the software malfunction. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recalled product
- Product
- Philips PIC iX Essentials REF:867093
- Manufacturer
- Philips North America
- Affected units
- 312
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)00884838122772
Distribution
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