Recall Z-0612-2019 · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Medical Systems Gmbh, DMC
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
| Date | Nov 7, 2018 |
| Status | Terminated |
| Reason | kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose. |
| Root cause | Software design (manufacturing process) |
| Action | On November 7, 2018, Philips Medical Systems distributed an URGENT MEDICAL DEVICE RECALL" notices dated 10/16/2018 to customers. The following are Actions to Be Taken by the Customer: **If the kV/mA lockin not functioning as specified**: The operator can recognize the issue by observing the increasing mA value. In general the system can be used according to the Instruction for Use without restrictions. **If the Stitching with SkyPlate aborts after first image**: There are no actions to be taken by the user in these situations. The customer is notified at the end of the stitching run that |
| Quantity | 146 |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163210 | Philips CombiDiagnost R90 Philips Medical Systems Dmc GmbH, Jan 31, 2017 |