FDA Device recall Z-0791-2014
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-R…
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-R… by Philips Medical Systems Cleveland, citing the DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than cl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0791-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-03-07 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | DC, IL, IN, MI, MO, NY, OH, OR, PA, TX, VT |
Product
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are 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
The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than clinicians would expect.
Identifiers
| code_info | Brilliance iCT: Model Number 728311 and 728306, Serial Number: 100103, 100019, 100023, 100170, 200047, 200013 200005 an…Brilliance iCT: Model Number 728311 and 728306, Serial Number: 100103, 100019, 100023, 100170, 200047, 200013 200005 and 100087. Brilliance 64: Model Number 728231 and 728326, Seial Number: 4003, 9745, 9875, 90135, 90169, 95414, 300003, 300004, 300005 and 300010. Brilliance CT Big Bore, Model Number: 728243, Serial Number: 7006, 7060, 7154, 7298 and 7349. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0791-2014%22
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