Philips M3150 Information Center Software Recalled for Component Failure
Philips is recalling 607 M3150 Information Center units worldwide due to a potential for early component failure. The software is used to display physiologic data and alarms.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Philips Electronics North America Corporation is recalling 607 units of the M3150 Information Center Local Database software. The affected models include 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, and 865127. The software is intended to display physiologic waves, parameters, and trends, provide data for strip recordings and printed reports, and annunciate alarms from networked medical devices.
The recall is due to a potential for early component failure. The affected products were shipped between June 9, 2008, and May 31, 2009. Affected units have a PC serial number range between 2UA8300XYZ and 2UA84510QW, though only a subset of these products are affected. The distribution was worldwide, including the United States, Canada, and numerous other countries.
Healthcare facilities and customers who received these units should contact Philips Electronics North America Corporation for further instructions on how to address the potential component failure.
The recalled product
- 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 disp
- Manufacturer
- Philips Electronics North America Corporation
- Hazard
- Affected units
- 607
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 2008 and May 31
- only a subset of these products are affected.
Distribution
Distributed nationwide across the United States.
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