Recall Z-0511-2018 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correct
| Date | Feb 3, 2018 (initiated Dec 15, 2017) |
| Status | Terminated |
| Reason | During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor. |
| Root cause | Under Investigation by firm |
| Action | Philips sent an Urgent Field Safety Notice letter dated December 15, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Philips representative. |
| Quantity | 1387 in total |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062298 | APOLLO GAMMA CAMERA SYSTEM Adac Laboratories, Aug 23, 2006 |