Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 25, 2014
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time t…
Spacelabs Healthcare Inc recalled Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07 - a moderate-severity action.
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07 was recalled by Spacelabs Healthcare Inc in June 25, 2014. Reason: Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, whe…. Check the official notice for the remedy. Verify recall #Z-1824-2014 with the FDA Devices before acting.
The recall
Spacelabs Healthcare Inc issued this moderate-severity FDA Devices recall-Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, whe….
- Moderate
- severity level
- 46 units
- affected scope
- Class II
- classification
- June 25, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1824-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1824-2014) was formally reported on June 25, 2014, with the manufacturer initiating the action on May 9, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Spacelabs Healthcare Inc is listed as the recalling firm, operating out of Snoqualmie, WA. Federal records list the affected scope as 46 units distributed within the US; 108 units distributed outside the US..
The documented reason for this recall is: Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on th… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US.. 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
46 units distributed within the US; 108 units distributed outside the US.
Related Recalls
6
3 from same agency
Product description
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Reason for recall
Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1824-2014 |
| Date reported | June 25, 2014 |
| Date initiated | May 9, 2014 |
| Recalling firm | Spacelabs Healthcare Inc |
| Firm location | Snoqualmie, WA |
| Affected scope | 46 units distributed within the US; 108 units distributed outside the US. |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US. |
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-1824-2014) 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? ▼
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07. Recalled by Spacelabs Healthcare Inc. Units affected: 46 units distributed within the US; 108 units distributed outside the US..
Why was this product recalled? ▼
Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 25, 2014. Severity: Moderate. Recall number: Z-1824-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1824-2014) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 June 25, 2014. 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.