Recall Z-1929-2019 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizi
| Date | Jun 3, 2019 |
| Status | Terminated |
| Reason | The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cover parts and/or protrusion of the cover into the bore diameter. |
| Root cause | Device Design |
| Action | On June 3, 2019, the firm notified their customers of the recall via an "Urgent Field Safety Notice Medical Device Correction" letter. Customers were advised to take the following actions: * The operator is instructed to observe the patient during motorized motion. In case of collision, the operator should use the E-Stop to abort all motions. " The operator is instructed to ensure accessories do not collide with gantry covers. Additionally, ensure that sheets, blankets and/or IV lines are not loose or hanging outside the Patient Pallet. " Ensure the patients arms/hands are positioned appropr |
| Quantity | 70 |
| Distribution | Worldwide Distribution - US Nationwide Domestic distribution to CA GA LA MD MI MN MO NE NJ NY OH TN TX VT WI. Foreign distribution to Mexico, Argentina Austria Belgium China Colombia France Germany Israel Italy Japan Latvia Luxembourg Netherlands Portugal Singapore Spain Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123599 | INGENUITY DIGITAL PET/CT Philips Healthcare (Cleveland), Jul 12, 2013 |