Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

System, Tomography Computed Emmission

FDA Recall Z-2259-2020 · Posted 2020-06-03

Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeKPS
Date Initiated2018-11-30
Product Quantity526 total units

Reason for Recall

GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.

Firm Action

GE Healthcare identified that a small number of Nuclear Medicine systems are operating without currently updated software.

Root Cause

Other

Distribution Pattern

Domestic Distribution: AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, IA, IL, IN, KY, LA,MA, MD, ME, MI, MN, MO, MS, NC, NE, NM, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT,VA, WI and WV. Foreign Distribution: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, France, Germany, Ghana, India, Israel, Italy, Japan, Korea, Malaisya, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Sweden, Taiwan, Thailand, Turkey and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080124VENTRI 1.1Ge Medical Systems F.I. Haifa · 2008-01-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑