Recall Z-0376-2017 ยท JAK System, X-Ray, Tomography, Computed
Philips Electronics North America Corporation
Philips Healthcare System X-ray Tomography Computed :
| Date | Mar 15, 2016 |
| Status | Terminated |
| Reason | It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips planned action: 1. Philips issued a customer notification letter on October 13, 2016. The letter includes a statement that the corrections will be made free of charge. 2. Philips will initiate a field corrective action to address the issue. 3. Philips will contact the customer and schedule an inspection to determine if the unit requires repair. 4. If repair is required, the couch horizontal linkage assembly will be replaced. For further questions please call (978) 659-3000. |
| Quantity | 1363 |
| Distribution | USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.