M3150 Information Center Local Database — Class II medical device recall Z-2528-2017
Terminated recall by Philips Electronics North America Corporation, reported 2017-06-21, distributed nationwide. Potential for early component failure.
| Recall number | Z-2528-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2010-12-17 |
| Classified | 2017-06-13 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2017-08-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, CZ, DE, ES, FI, FR, GB, GR, ID, IE, IN, IT, JP, KE, KR, NL, PH, PL, SE, TH, TR |
| Quantity | 607 units |
| Model numbers | 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127 |
Product
M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors
Reason for recall
Potential for early component failure.
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-2528-2017. 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.