Recall Z-0217-2020 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
| Date | Nov 1, 2019 (initiated Sep 19, 2019) |
| Status | Terminated |
| Reason | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit. |
| Root cause | Nonconforming Material/Component |
| Action | On September 19, 2019 the firm distributed Urgent Field Safety Notice (FSN) Medical Device Correction letters by direct communication from Philips Field Service Engineers instructing them to: - Discontinue system use until further notice - Inform those who need to be aware within your organization or any organization where the potentially affected devices have been transferred (If appropriate). - Maintain this notice with your system Instructions for Use (IFU) until the correction is made to the system. ACTIONS PLANNED BY PHILIPS: Philips Healthcare is distributing this FSN to all affected cu |
| Quantity | 1167 in total |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033254 | FORTE GAMMA CAMERA SYSTEM Adac Laboratories, Oct 22, 2003 |