Draeger Infinity Acute Care System — Class II medical device recall Z-0939-2013
Terminated recall by Draeger Medical, Inc., reported 2013-03-20, distributed in CA, IL, MA. The displayed value for the invasive blood pressure measurement of the IACS was different than the actual pati
| Recall number | Z-0939-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2012-12-13 |
| Classified | 2013-03-11 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2013-05-20 |
| Distributed | CA, IL, MA |
| Quantity | 260 |
| Model numbers | MS20783 |
Product
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
Reason for recall
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.
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-0939-2013. 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.