FDA Device recall Z-1964-2015
Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500 by Hamilton Medical, citing an issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1964-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-01 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hamilton Medical |
| Distribution | US |
Product
Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
Reason
An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.
Identifiers
| code_info | PN 155500, all lot codes. |
|---|
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-1964-2015%22
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