Z-0242-2022 Class II Ongoing
FDA device recall Z-0242-2022 was initiated by GE Healthcare, LLC on June 30, 2021 and is designated Class II. Reason for recall: The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this… The recall status is ongoing. Affected quantity: 105 in total.
Recall Details
- Product Type
- Devices
- Report Date
- December 1, 2021
- Initiation Date
- June 30, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 105 in total
Product Description
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Reason for Recall
The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.
Distribution Pattern
Worldwide and US Nationwide Distribution
Code Information
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition