Z-2259-2020 Class II Ongoing
FDA device recall Z-2259-2020 was initiated by GE Healthcare, LLC on Nov 30, 2018 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 526 total units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 10, 2020
- Initiation Date
- Nov 30, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 526 total units
Product Description
Reason for Recall
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2259-2020
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026