FDA Device recall Z-2451-2012
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, O…
- FDA Device
- Class II
- terminated
- Published 2012-10-03
On 2012-10-03 the FDA classified a Class II recall of Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, O… by Philips Medical Systems Cleveland, citing A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2451-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-21 |
| Published | 2012-10-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AL, AZ, CA, CO, FL, GA, IL, KS, KY, MI, MS, NJ, NM, NV, NY, OH, TX, WA, WI |
Product
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are 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. GEMINI Dual is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as X-ray transmission images of these areas. The PET and CT images are registered and displayed in a fused format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.
Reason
A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
Identifiers
| code_info | System Code #: 728130; Serial #: 8128, 8158 & 8369. System Code #: 728256; Serial #: 3695, 3703, 371 &, 3719. Sys…System Code #: 728130; Serial #: 8128, 8158 & 8369. System Code #: 728256; Serial #: 3695, 3703, 371 &, 3719. System Code #: 728246; Serial #: 3463, 3508, 3519, 3548, 3552, 3591, 3592, 3593, 3603, 3637, 3648, 3654, 3659, 3661, 3675, 3679, 3687, 3692, 5451, 5515, 5543, 5567, 5583, 5586, 5658, 5664, 5675, 5697, 5707, 5749, 5752, 5774, 5807, 5813, 5815, 5845, 5846, 5852, 5866, 5872, 5910, 5963, 5968, 6028, 6036, 6045, 6071 & 6126. System Code #: 882160; Serial #: 97, 102, 103, 105, 106, 107, 109, 110, 111, 113, 114, 115, 116, 117, 118, 121, 122, 123, 124, 125, 126, 127, 131, 132, 133, 134, 135, 136, 137, 139, 140, 141, 143, 144, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, , 63, 164, 165, 167, 1065 & 6119. |
|---|
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-2451-2012%22
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