FDA Devices recall · Reported August 14, 2019
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion series (within the limits of the used Operating Room table) are intended for use to perform: Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical app
The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.
Philips North America, LLC recalled Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray s… - a moderate-severity action.
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray s… was recalled by Philips North America, LLC in August 14, 2019. Reason: The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains pow…. Check the official notice for the remedy. Verify recall #Z-2205-2019 with the FDA Devices before acting.
The recall
Philips North America, LLC issued this moderate-severity FDA Devices recall-The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains pow….
- Moderate
- severity level
- 834 units
- affected scope
- Class II
- classification
- August 14, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2205-2019 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 moderate 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 Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion series (within the limits of the used Operating Room table) are intended for use to perform: Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: . The Azurion series can be used in a hybrid Operating Room. The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.
Reason for recall
The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2205-2019 |
| Date reported | August 14, 2019 |
| Date initiated | July 16, 2019 |
| Recalling firm | Philips North America, LLC |
| Firm location | Andover, MA |
| Affected scope | 834 |
| Distribution | US Nationwide Distribution Foreign: Canada Argentina AUSTRALIA Austria Azerbaijan Bahrain Bangladesh Belgium Bosnia and Herzegovina Brazil Bulgaria Chile Colombia CROATIA Denmark ECUADOR Egypt Finland France Germany … |
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-2205-2019) 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 (Moderate), 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