Recall Z-2112-2016 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.
| Date | Jun 21, 2016 |
| Status | Terminated |
| Reason | Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack. |
| Root cause | Nonconforming Material/Component |
| Action | Philips is informing the consignee of this issue through: Customer Information Letter (CIL) 72800656 . International consignees will be contacted by Philips Healthcare Global Market representatives, who will distribute the CIL. A Field Service Engineer (FSE) will contact the customers to schedule a time to conduct the appropriate correction through Field Change Order (FCO) 72800656 once it is available. This FCO will address the above identified issue. A response form sent to the customer via certified mail. This package will also contain a return receipt. |
| Quantity | 1 unit |
| Distribution | Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |