Brilliance CT 16-Slice Water — Class II medical device recall Z-1338-2013
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-05-29, distributed nationwide. Philips Healthcare received a report from the field stating when they viewed the CTDIVol information from the
| Recall number | Z-1338-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2013-03-12 |
| Classified | 2013-05-20 |
| Reported by FDA | 2013-05-29 |
| Terminated | 2015-06-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CN, CO, DE, DK, ES, FR, GB, IE, IL, IN, IQ, IT, JP, KR, MX, NI, NL, NO, NZ, PH, PL, PT, SE, SG, TH, TR, VE |
| Quantity | 515 units |
| Serial numbers | 2501, 2502, 2505, 2508, 2509, 2510, 2513, 2515, 2516, 2517, 2518, 2522, 2523, 2524, 2525, 2526, 2528, 2529, 2530, 2531, 2533, 2534, 2535, 2539, 2540 and 446 more |
Product
Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Philips Medical Systems (Cleveland), Inc., 595 Miner Road, Cleveland, OH 44143 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. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Reason for recall
Philips Healthcare received a report from the field stating when they viewed the CTDIVol information from the PACS system, the calculations were too high. Instead of storing the CTDIVol value for each slice in the DICOM tag, the system took the sum of all CTDIVol values from all the images in the dataset and stored this value in the DICOM tag, resulting in incorrect information.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1338-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.