Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported May 11, 2022
Azurion systems with software release R1.x
In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selec…
Philips Medical Systems Nederland B.v. recalled Azurion systems with software release R1.x — a moderate-severity action.
Azurion systems with software release R1.x was recalled by Philips Medical Systems Nederland B.v. in May 11, 2022. Reason: In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Ad…. Check the official notice for the remedy. Verify recall #Z-0886-2022 with the FDA Devices before acting.
The recall
Philips Medical Systems Nederland B.v. issued this moderate-severity FDA Devices recall — In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Ad….
- Moderate
- severity level
- Class II
- classification
- May 11, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0886-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0886-2022) was formally reported on May 11, 2022, with the manufacturer initiating the action on May 26, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Philips Medical Systems Nederland B.v. is listed as the recalling firm, operating out of Best, N/A. Federal records list the affected scope as 722 systems.
The documented reason for this recall is: In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a soft… Distribution data in the federal record shows the product reached: US Nationwide and Worldwide Distribution. Distribution scope 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. 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.
Affected scope
722 systems
Related Recalls
6
6 from same agency
Product description
Azurion systems with software release R1.x
Reason for recall
In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0886-2022 |
| Date reported | May 11, 2022 |
| Date initiated | May 26, 2021 |
| Recalling firm | Philips Medical Systems Nederland B.v. |
| Firm location | Best, N/A |
| Affected scope | 722 systems |
| Distribution | US Nationwide and Worldwide Distribution |
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-0886-2022) 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.
Frequently Asked Questions
What product was recalled? ▼
Azurion systems with software release R1.x. Recalled by Philips Medical Systems Nederland B.v.. Units affected: 722 systems.
Why was this product recalled? ▼
In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 11, 2022. Severity: Moderate. Recall number: Z-0886-2022.
Where was the recalled product distributed? ▼
Distribution: US Nationwide and Worldwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0886-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 11, 2022.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.