The Recall Desk

FDA (Devices) recall action 82914

Philips North America, LLC recalled 2 products on 2019-06-19

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-06-19
Critical
0
Units
12,571

Why these products were recalled

Infusion Pump Data Storage Accuracy-Data from the 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 patients chart or electronic medical record at exactly 100 times the actual bolus rate, infusion rate and total volume values

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2019-06-19

    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.

    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 I
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-06-19

    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.

    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
    Category
    Distribution
    0 states