Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 28, 2016
AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intend
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Radiometer America Inc recalled AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0… - a moderate-severity action.
AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0… was recalled by Radiometer America Inc in December 28, 2016. Reason: Design error when displaying additional information in the patient view window; error may result in misreadin…. Check the official notice for the remedy. Verify recall #Z-0899-2017 with the FDA Devices before acting.
The recall
Radiometer America Inc issued this moderate-severity FDA Devices recall-Design error when displaying additional information in the patient view window; error may result in misreadin….
- Moderate
- severity level
- Class II
- classification
- December 28, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0899-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0899-2017) was formally reported on December 28, 2016, with the manufacturer initiating the action on November 23, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Radiometer America Inc is listed as the recalling firm, operating out of Brea, CA. Federal records list the affected scope as 7 total (2 in US).
The documented reason for this recall is: Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value. Distribution data in the federal record shows the product reached: Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 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
7 total (2 in US)
Related Recalls
6
3 from same agency
Product description
AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
Reason for recall
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0899-2017 |
| Date reported | December 28, 2016 |
| Date initiated | November 23, 2016 |
| Recalling firm | Radiometer America Inc |
| Firm location | Brea, CA |
| Affected scope | 7 total (2 in US) |
| Distribution | Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates. |
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-0899-2017) 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? ▼
AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.. Recalled by Radiometer America Inc. Units affected: 7 total (2 in US).
Why was this product recalled? ▼
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2016. Severity: Moderate. Recall number: Z-0899-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0899-2017) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 28, 2016. 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 July 2026.