Philips IntelliBridge System Recall for Infusion Pump Data Storage Accuracy Issues
Philips is recalling IntelliBridge Systems configured with comma decimal separators because infusion pump data may be recorded at 100 times the actual values.
What this means for you
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 by definition is unlikely to cause adverse health consequences. The hazard involves data recording errors rather than direct physical harm, fitting the Moderate severity criteria for low-risk issues.
Plain-English summary
Philips North America, LLC is recalling 180 units of the IntelliBridge System configured with a regional setting that uses a comma for a decimal separator. The affected products include the 866417 IntelliBridge System C.01 (or later) and the 866418 IntelliBridge System C.01 upgrade (or later). The system is indicated for use in data collection and clinical information management in professional healthcare facilities.
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 system is not intended for monitoring purposes or to control clinical devices.
The affected units were distributed worldwide, including in the United States and numerous foreign countries. Healthcare professionals should verify their configuration and contact Philips for further instructions.
The recalled product
- Product
- Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 IntelliBridge System C.01 (or later) 866418 IntelliBridge System C.01 upgrade (or later) Product Usage: The IntelliBridge System is indicated for use in data
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 180
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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