Hamilton G5 with software version between v2 — Class II medical device recall Z-1624-2016
Terminated recall by Hamilton Medical, Inc., reported 2016-05-18. After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting t
| Recall number | Z-1624-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical, Inc., Reno, NV, United States |
| Recall initiated | 2016-03-09 |
| Classified | 2016-05-09 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2017-06-29 |
| Quantity | 1,115 |
| Serial numbers | 10001, 10012, 10018, 10019, 10020, 10021, 10023, 10027, 10028, 10029, 10030, 10031, 10032, 10033, 10034, 10035, 10036, 10037, 10038, 10039, 10040, 10041, 10042, 10043, 10044 and 475 more |
| Model numbers | 1590001, 1590002 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1624-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.