GE Healthcare Solar 8000M System, a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment
FDA Recall Z-0285-2009 · Posted 2009-01-05
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeDSI
Date Initiated2008-04-02
Date Terminated2012-05-17
Product Quantity2782
Reason for Recall
A software error has been discovered when using Combination Monitoring with Solar 8000M/i - PDM - Telemetry in combo mode. This error has only been noted with this particular configuration and mode of monitoring. It has not been observed in other monitoring applications. The software error will result in a reset of the Solar 8000M/i, causing a loss of monitoring for approximately 1-2 minutes a
Firm Action
A GE Healthcare consignee letter was sent out 9/9/08. The letter dated August 26, 2008 was addressed to Healthcare Administrator/Risk Manger. The letter described the problem, product and provided recommendation.
Root Cause
Software design
Distribution Pattern
Nationwide to: AL, AR, AZ, CA, FL, GA, IA, ID, IL, IN, MA, MI, MN, MO, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, and WI. OUS to include: Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, France, Germany, Indonesia, Ireland, Italy, Jordan, Korea, Lebanon, Lithuania, Malaysia, Netherlands, Norway, Pakistan, Saudi Arabia, Spain, Sweden, United Kingdom, and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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