Z-1396-2018 Class II Terminated
FDA device recall Z-1396-2018 was initiated by Philips Medical Systems (Cleveland) Inc on Feb 21, 2018 and is designated Class II. Reason for recall: Surview scan with tube current lower than 30 mA is unable to be initialized. The recall status is terminated (terminated Apr 10, 2020). Affected quantity: 291.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 25, 2018
- Initiation Date
- Feb 21, 2018
- Termination Date
- Apr 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 291
Product Description
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
Reason for Recall
Surview scan with tube current lower than 30 mA is unable to be initialized.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
Code Information
Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1396-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026