Recall Z-2386-2012 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
| Date | Sep 14, 2012 (initiated Aug 24, 2012) |
| Status | Terminated |
| Reason | On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry. |
| Root cause | Process design |
| Action | An "Urgent Medical Device Correction" Field Safety Notice dated August 24, 2012 was sent to all US consignees via certified mail. The problem was described and recommended actions were provided. Philips Key Market representatives distributed the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Orders. US Customer contact number: 1 800-722-9377. |
| Quantity | 328 units |
| Distribution | Worldwide distribution, Nationwide (US) including the states AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, and VA and the countries of Albania, Argentina, Australia, Belgium, Brazil, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Italy, |
| FDA record | Open on fda.gov |