Recall Z-1328-2020 · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Medical Systems Gmbh, DMC
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
| Date | Feb 20, 2020 (initiated Dec 19, 2019) |
| Status | Terminated |
| Reason | When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production. |
| Root cause | Software design |
| Action | On December 19, 2019, the firm initiated mailing of the Medical Device Recall Letter to all affected customers. Customers were advised to use the system according to the Instructions for Use (IFU). In particular: Error 80 issue: The issue can be prevented if the operator avoids tilting the table by Table Up/Down joystick and instead uses the Table Tilt Left/Right joystick. If the issue occurs, the operator should remove the patient from the table and bring him/her to upright position so that the contrast agent does not enter the brain. SPDU issue: The user should pay attention to whether i |
| Quantity | 116 |
| Distribution | Worldwide distribution US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MI, MN, MO, MT, NC, NJ, NY, OH, TX, UT, VA and countries of Canada, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, China, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Dominican Republic, Eg |
| 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 |