Recall Z-0510-2018 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and no
| 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 |