Philips Patient Information Center iX Recall for Infusion Pump Data Accuracy
Philips is recalling Patient Information Center iX software because infusion pump data may be recorded at 100 times the actual rate.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a data recording error rather than a direct physical injury, fitting the Moderate severity criteria for minor errors or low-risk issues.
Plain-English summary
Philips North America, LLC is recalling the Patient Information Center iX software. The recall affects specific configurations where the regional setting uses a comma for a decimal separator. The affected product codes are 866389 Patient Information Center iX B.01 (or later) and 866390 Patient Information Center iX B.01 upgrade (or later).
The recall is due to a data storage accuracy issue. Data from BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX using a LAN driver may be recorded in the patient's chart or electronic medical record at exactly 100 times the actual bolus rate, infusion rate, and total volume values.
The affected units were distributed worldwide, including in the United States and numerous foreign countries. The source text does not specify the number of affected units or report any illnesses or injuries. Users should verify their regional settings and consult the manufacturer for corrective actions.
The recalled product
- Product
- Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the…
- Manufacturer
- Philips North America, LLC
- Affected units
- 12,391
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips North America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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