Recall Z-1003-2013 ยท JAK System, X-Ray, Tomography, Computed
Philips Healthcare Inc.
Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equi
| Date | Apr 17, 2013 (initiated Apr 5, 2010) |
| Status | Terminated |
| Reason | Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips Healthcare proposed corrective action plan (CAP) is comprised of the following elements: * Updating procedures in manufacturing to verify, either through software calibration or through gage-pin measurement, that A-plane collimation is appropriate to the design specification. It is our understanding that these procedures have been implemented. * For refurbished PET/CT and SPECT/CT systems distributed by Philips, the manufacturing process now requires that CTDI testing be conducted in addition to air testing and that each system meet updated CTDI tolerance limits to be published in th |
| Quantity | 2089 US 4036 ROW |
| Distribution | Worldwide Distribution including USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.