Delta — Class II medical device recall Z-1772-2017
Terminated recall by Draegar Medical Systems, Inc., reported 2017-04-19, distributed nationwide. It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limi
| Recall number | Z-1772-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draegar Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2017-03-28 |
| Classified | 2017-04-10 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2018-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 2,156 |
| Model numbers | MS18597 |
Product
Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patients medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia. For combination with Scio gas module: Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the In-finity monitors.
Reason for recall
It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.
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-1772-2017. 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.