FDA Devices recall · Reported June 19, 2019
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 collection and clinical information management either directly or through networks with independent bedside devices. The system is not intended for monitoring purposes, nor is the system intended to control any of the c
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 Ce…
Philips North America, LLC recalled Philips IntelliBridge System configured with a regional setting which uses a comma for a … - a low-severity action.
Philips IntelliBridge System configured with a regional setting which uses a comma for a … was recalled by Philips North America, LLC in June 19, 2019. Reason: Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps trans…. Check the official notice for the remedy. Verify recall #Z-1772-2019 with the FDA Devices before acting.
The recall
Philips North America, LLC issued this low-severity FDA Devices recall-Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps trans….
- Low
- severity level
- 180 units
- affected scope
- Class III
- classification
- June 19, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1772-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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 collection and clinical information management either directly or through networks with independent bedside devices. The system is not intended for monitoring purposes, nor is the system intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to. The IntelliBridge solution is intended for use in professional healthcare facilities by trained healthcare professionals.
Reason for recall
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1772-2019 |
| Date reported | June 19, 2019 |
| Date initiated | April 29, 2019 |
| Recalling firm | Philips North America, LLC |
| Firm location | Andover, MA |
| Affected scope | 180 units |
| Distribution | Worldwide Distribution - US Nationwide Foreign: Andorra Aruba Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Costa Rica Croatia Czech Republic Denmar… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1772-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026