Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 18, 2016
Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.
After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as ex…
Hamilton Medical, Inc. recalled Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 a… - a moderate-severity action.
Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 a… was recalled by Hamilton Medical, Inc. in May 18, 2016. Reason: After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting …. Check the official notice for the remedy. Verify recall #Z-1624-2016 with the FDA Devices before acting.
The recall
Hamilton Medical, Inc. issued this moderate-severity FDA Devices recall-After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting ….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- May 18, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1624-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1624-2016) was formally reported on May 18, 2016, with the manufacturer initiating the action on March 9, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Hamilton Medical, Inc. is listed as the recalling firm, operating out of Reno, NV. Federal records list the affected scope as 1115.
The documented reason for this recall is: After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected. Distribution data in the federal record shows the product reached: US distribution only.. 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
1115
Related Recalls
6
3 from same agency
Product description
Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.
Reason for recall
After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1624-2016 |
| Date reported | May 18, 2016 |
| Date initiated | March 9, 2016 |
| Recalling firm | Hamilton Medical, Inc. |
| Firm location | Reno, NV |
| Affected scope | 1115 |
| Distribution | US distribution only. |
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-1624-2016) 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.
- 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? ▼
Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.. Recalled by Hamilton Medical, Inc.. Units affected: 1115.
Why was this product recalled? ▼
After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2016. Severity: Moderate. Recall number: Z-1624-2016.
Where was the recalled product distributed? ▼
Distribution: US distribution only..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1624-2016) 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 May 18, 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.