Recall Z-2009-2019 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
BrightView SPECT, Model Number 882480
| Date | Jun 10, 2019 |
| Status | Terminated |
| Reason | An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released. |
| Root cause | Under Investigation by firm |
| Action | Urgent Field Safety Notice Medical Device Correction letters dated 6/4/19 were sent to customers. Discontinue Use of the BrightView Handcontroller. Remove the handcontroller from the charging station and store in a secure location inaccessible by technicians, at least 20 meters (65 feet) away from the system and outside the imaging room. If 20 meters (65 feet) is not possible, then store the handcontroller in an area that is shielded, such as a hot lab. Do not dispose of the hand controller, as it will be needed once a solution is identified. Instead of the physical handcontroller, use th |
| Quantity | 696 |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080927 | BRIGHTVIEW VCT IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc., Apr 11, 2008 |