FDA Device recall Z-0151-2016
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31
- FDA Device
- Class I
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class I recall of HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31 by Hamilton Medical, citing ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regard….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0151-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-04-22 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hamilton Medical |
| Distribution | US |
Product
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
Reason
Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult).
Identifiers
| code_info | software versions between V2.00 and V2.31. Ventilator catalog number: 1590001; Software catalog number: 159700. Se…software versions between V2.00 and V2.31. Ventilator catalog number: 1590001; Software catalog number: 159700. Serial numbers: 1231 1233 1234 1235 1014 1296 1593 1594 1595 1626 1628 1629 1631 1632 1633 1634 1637 1693 1697 1862 1863 2021 2411 2412 2413 2414 2416 2417 2418 2591 2592 2593 2594 2595 2681 2683 2686 2687 2689 2776 2777 2778 2779 2780 2781 2784 2785 2786 2787 2789 2790 2793 2794 2798 2803 2887 2947 2948 2951 2952 2953 2954 2958 2959 3362 3366 3368 3369 3371 3372 3375 3376 3377 3378 3379 3382 3383 3384 3548 3596 3598 3599 3600 3602 3609 3610 3612 3861 3869 3911 3912 3913 3976 3977 3978 3981 3987 3988 3990 3991 4004 4009 4012 4015 4016 4017 4019 4021 4023 4024 4026 4027 4028 4029 4030 4031 4034 4035 4037 4038 4050 4052 4053 4054 4059 4060 4071 4072 4076 4078 4083 4084 4086 4087 4089 4153 4155 4156 4159 4161 4180 4196 4197 4200 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0151-2016%22
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