GE Healthcare Solar 8000M System…

Date posted by the FDA

Jan. 5, 2009

Status

Terminated

Filed by

GE Healthcare

Product

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

Reason

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

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.

Quantity

2782

Codes and lots

Serial numbers: PA1257732, PA1257733, PA1257734, SCZ07200027GA, SCZ07200028GA, SCZ07200029GA, SCZ07200030GA, SCZ07200031GA, SCZ07200032GA, SCZ07200033GA, SCZ07200034GA, SCZ07200035GA, SCZ07220036GA, SCZ07220037GA, SCZ07220038GA, SCZ07220039GA, SCZ07220040GA, SCZ07220041GA, SCZ07220042GA, SCZ07220043GA, SCZ07220044GA, SCZ07220045GA, SCZ07220046GA, SCZ07220047GA, SCZ07220048GA, SCZ07220049GA, SCZ07220050GA, SCZ07220051GA, SCZ07220052GA, SCZ07220053GA, SCZ07220054GA, SCZ07220055GA, SCZ07220056GA, SCZ07220058GA, SCZ07220059GA, SCZ07220060GA, SCZ07220061GA, SCZ07220067GA, SCZ07220068GA, SCZ07220069GA, SCZ07220070GA, SCZ07220072GA, SCZ07220073GA, SCZ07220076GA, SCZ07220077GA, SCZ07220078GA, SCZ07220079GA, SCZ07220080GA, SCZ07220081GA, SCZ07220082GA, SCZ07220084GA, SCZ07220085GA, SCZ07220086GA, SCZ07220087GA, SCZ07220088GA, SCZ07220089GA, SCZ07220090GA, SCZ07220091GA, SCZ07220092GA, SCZ07220093GA, SCZ07220094GA, SCZ07220095GA, SCZ07220096GA, SCZ07220097GA, SCZ07220098GA, SCZ07220099GA, SCZ07220100GA, SCZ07220101GA, SCZ07220102GA, SCZ07220103GA, SCZ07220104GA, SCZ07220105GA, SCZ07220106GA, SCZ07220107GA, SCZ07220108GA, SCZ07220109GA, SCZ07220110GA, SCZ07220111GA, SCZ07220112GA, SCZ07220113GA, SCZ07220114GA, SCZ07220115GA, SCZ07230116GA, SCZ07230158GA, SCZ07230162GA, SCZ07230163GA, SCZ07230164GA, SCZ07230165GA, SCZ07230166GA, SCZ07230167GA, SCZ07230168GA, SCZ07230169GA, SCZ07230170GA, SCZ07230171GA, SCZ07230172GA, SCZ07230173GA, SCZ07230174GA, SCZ07230175GA, SCZ07230176GA, SCZ07230177GA, SCZ07230178GA, SCZ07230179GA, SCZ07230180GA, SCZ07230181GA, SCZ07230182GA, SCZ07230183GA, SCZ07230184GA, SCZ07230185GA, SCZ07230191GA, SCZ07230209GA, SCZ07230210GA, SCZ07230211GA, SCZ07230212GA, SCZ07230213GA, SCZ07230214GA, SCZ07230215GA, SCZ07230216GA, SCZ07230217GA, SCZ07230218GA, SCZ07230219GA, SCZ07230220GA, SCZ07230221GA, SCZ07230222GA, SCZ07230223GA, SCZ07230224GA, SCZ07230225GA, SCZ07230226GA, SCZ07230227GA, SCZ07230228GA, SCZ07230229GA, SCZ07230232GA, SCZ07240255GA, SCZ07240256GA, SCZ07240257GA, SCZ07240258GA, SCZ07240259GA, SCZ07240260GA, SCZ07240261GA, SCZ07240262GA, SCZ07240263GA, SCZ07240264GA, SCZ07240265GA, SCZ07240266GA, SCZ07240267GA, SCZ07240268GA, SCZ07240269GA, SCZ07240270GA, SCZ07240271GA, SCZ07240272GA, SCZ07240273GA, SCZ07240274GA, SCZ07240275GA, SCZ07240276GA, SCZ07240277GA, SCZ07240278GA, SCZ07240279GA, SCZ07240280GA, SCZ07240281GA, SCZ07240282GA, SCZ07240283GA, SCZ07240284GA, SCZ07240285GA, SCZ07240286GA, SCZ07240287GA, SCZ07240288GA, SCZ07240289GA, SCZ07240290GA, SCZ07240291GA, SCZ07240292GA, SCZ07240293GA, SCZ07240294GA, SCZ07240295GA, SCZ07240296GA, SCZ07240297GA, SCZ07240298GA, SCZ07240299GA, SCZ07240300GA, SCZ07240301GA, SCZ07240302GA, SCZ07240303GA, SCZ07240304GA, SCZ07240306GA, SCZ07240307GA, SCZ07240308GA, SCZ07240310GA, SCZ07240321GA, SCZ07240323GA, SCZ07240324GA, SCZ07240329GA, SCZ07240346GA, SCZ07240347GA, SCZ07240348GA, SCZ07240349GA, SCZ07240350GA, SCZ07240351GA, SCZ07240352GA, SCZ07240353GA, SCZ07240387GA, SCZ07240388GA…

Recall started

April 2, 2008

Device type

Detector And Alarm, Arrhythmia

Root cause (FDA)

Software design

What the company told customers

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.

Recall number

Z-0285-2009

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0285-2009. The agency record governs; check it and the company before acting.