Cl Il Datex-Ohmeda S/5

Company:GE Medical Systems Information Tecnology.
Date of Enforcement Report 11/18/2009
Class:ll

PRODUCT
1) Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients. Recall # Z-1994-2009;

2) Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients. Recall # Z-1995-2009

REASON
GE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate (HR) was displaying as —(3 dashes) when the monitor was used continuously for 49 days without a cold start. A missed alarm or missed HR value could cause a delay in recognition of a cardiac event that may result in a serious injury that is permanent or life threatening. There were no reported patient injuries or illnesses for the use of this device in conjunction with this device correction.

RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems Information Tecnology, Wauwatosa, WI, by letter dated February 6, 2006.
Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,380 units

DISTRIBUTION
Italy, Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Israel, Jordan, Lithuania, Italy, Macedonia, Malaysia, Mexico, Netherland, Nicaragua, Norway, Poland, Portugal, Puerto Rico, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Syria, Turkey, United Arab Emirates, United Kingdom, Venezuela

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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Partners located in the US (CA, FL, MA, MN) and Italy.