Reported Jun 19, 2019 · Terminated
Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator:…
Philips North America, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips Patient Information Center iX configured with a regional setting which
- uses a comma for a decimal separator866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01
- upgrade (or later) Product UsageThe intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors
- Lot codes and dates
- 866389 Patient Information Center iX B.01 (or later) 866390 Patient Information Center iX B.01 upgrade (or later)
- Amount recalled
- 12,391
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was 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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips North America, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.