Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported March 2, 2016
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia adminis
Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re…
Maquet Cardiovascular Us Sales, Llc recalled Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia Syst… - a critical-severity action.
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia Syst… was recalled by Maquet Cardiovascular Us Sales, Llc in March 2, 2016. Reason: Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs…. Check the official notice for the remedy. Verify recall #Z-0804-2016 with the FDA Devices before acting.
The recall
Maquet Cardiovascular Us Sales, Llc issued this critical-severity FDA Devices recall-Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs….
- Critical
- severity level
- 7 units
- affected scope
- Class I
- classification
- March 2, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0804-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0804-2016) was formally reported on March 2, 2016, with the manufacturer initiating the action on December 10, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Maquet Cardiovascular Us Sales, Llc is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as 7 units within US.
The documented reason for this recall is: Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few… Distribution data in the federal record shows the product reached: US Nationwide in the states of CA, NY, and OR. 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 high 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 units within US
Related Recalls
6
3 from same agency
Product description
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.
Reason for recall
Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues. Only the Model C20 is affected in the US.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0804-2016 |
| Date reported | March 2, 2016 |
| Date initiated | December 10, 2015 |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Firm location | Wayne, NJ |
| Affected scope | 7 units within US |
| Distribution | US Nationwide in the states of CA, NY, and OR |
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-0804-2016) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 7 units within US.
Why was this product recalled? ▼
Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues. Only the Model C20 is affected in the US.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2016. Severity: Critical. Recall number: Z-0804-2016.
Where was the recalled product distributed? ▼
Distribution: US Nationwide in the states of CA, NY, and OR.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0804-2016) 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 March 2, 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.