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Open, Classified

System, Tomography Computed Emmission

FDA Recall Z-2258-2020 · 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.

K051855VENTRIGe Medical Systems F.I. Haifa · 2005-08-02

Official Source

View FDA Recall →

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

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