Z-2583-2018 Class II Terminated
FDA device recall Z-2583-2018 was initiated by GE Healthcare, LLC on May 24, 2018 and is designated Class II. Reason for recall: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply). The recall status is terminated (terminated Feb 8, 2019). Affected quantity: 42 units total.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 8, 2018
- Initiation Date
- May 24, 2018
- Termination Date
- Feb 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 units total
Product Description
CT Goldseal Optima CT 600
Reason for Recall
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Distribution Pattern
Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
Code Information
Serial Number 51941YC3, System ID Number 406434660
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2583-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026