Recall Z-2059-2011 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-
| Date | Apr 26, 2011 (initiated Mar 10, 2011) |
| Status | Terminated |
| Reason | The Philips MX 16-slice CT scanners are subject to recall/field correction due to a problem encountered with the units when using the 'Combine Viewing' Option. The firm determined that inaccurate dimension measurements display when using the Combine Viewing Option. Moreover, if the dimension measurements from merged images created using this option are used, there is a potential for applying inac |
| Root cause | Other |
| Action | Philips Healthcare issued an 'URGENT- Field Safety Notice MX 16-slice' (dated 3/10/2011) concerning a software issue to customers. The notification informed the firm's users/customers of the potential for inaccurate dimension measurements produced by the MX 16-slice CT scanners when using the Combine Function Viewing Option. Moreover, the letter notified customers of the potential for patient misdiagnosis in the event that inaccurate dimension measurements are used by a physician for reference. The Field Safety Notice described the following: 1) How to identify the affected product; 2) What |
| Quantity | 25 units were distributed domestically & 168 system units were distributed both domestically & internationally |
| Distribution | Worldwide Distribution -- United States (AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, SC and TX) including Puerto Rico and countries of Albania, Argentina, Australia, Belgium Brazil, Chile, Columbia, Dominican Republic, Ecuador, Germany, Greece, India, Indonesia, Italy, japan, Kenya, Lebanon, |
| FDA record | Open on fda.gov |