System, Tomography Computed Emmission
Reported: June 10, 2020 Initiated: November 30, 2018 #Z-2258-2020
Product Description
System, Tomography Computed Emmission
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 526 total units
- Distribution
- 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.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
System, Tomography Computed Emmission. Recalled by GE Healthcare, LLC. Units affected: 526 total units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 10, 2020. Severity: Moderate. Recall number: Z-2258-2020.
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