# FDA recall Z-2528-2017

> **Philips Electronics North  America Corporation** · Class II · device recall initiated 2010-12-17.

## 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.

## Distribution

Worldwide Distribution - US (Nationwide)  OUS:   CANADA  ARGENTINA  AUSTRALIA  AUSTRIA  BAHRAIN  BELGIUM  BRAZIL  CHILE  CHINA  COLOMBIA  CZECH REPUBLIC  FINLAND  FRANCE  GERMANY  GREECE  INDIA  INDONESIA  IRELAND  ITALY  JAPAN  KENYA  KOREA, REPUBLIC OF  NETHERLANDS  PHILIPPINES  POLAND  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TURKEY  UNITED KINGDOM

## Key facts

- **Recall number:** Z-2528-2017
- **Recalling firm:** Philips Electronics North  America Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2010-12-17
- **Report date:** 2017-06-21
- **Termination date:** 2017-08-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2528-2017

## Citation

> AI Analytics. FDA recall Z-2528-2017. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-2528-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*