FDA Device recall Z-0939-2013
Draeger Infinity Acute Care System (IACS) Monitoring Solution
- FDA Device
- Class II
- terminated
- Published 2013-03-20
On 2013-03-20 the FDA classified a Class II recall of Draeger Infinity Acute Care System (IACS) Monitoring Solution by Draeger Medical, citing the displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccura….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0939-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-13 |
| Published | 2013-03-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Draeger Medical |
| Distribution | CA, IL, MA |
Product
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
Reason
The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.
Identifiers
| code_info | Catalog Number MS20783 (Infinity MCable-Dual Hemo) |
|---|
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-0939-2013%22
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