Infinity Acute Care System — Class II medical device recall Z-1813-2018
Terminated recall by Draegar Medical Systems, Inc., reported 2018-05-23, distributed nationwide. Software anomaly resulting in the loss of patient settings and stored patient data.
| Recall number | Z-1813-2018 |
|---|---|
| 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 | 2018-03-28 |
| Classified | 2018-05-14 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2020-04-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, EG, ES, FI, FR, GB, GH, GR, HK, HU, ID, IE, IN, IT, JO, JP, KE, KR, KW, LT, LV, MX, MY, NL, NO, NZ, PA, PE, PK, PL, PT, QA, SA, SE, SG, SI, TH, TR, TT, VN, ZA |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04049098009751, 04049098009799, 04049098054409, 04049098054447, 04049098054454 |
| Model numbers | MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818 |
Product
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.
Reason for recall
Software anomaly resulting in the loss of patient settings and stored patient data.
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-1813-2018. 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.