Recall Z-2110-2016 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
| Date | Jun 14, 2016 |
| Status | Terminated |
| Reason | Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel. |
| Root cause | Nonconforming Material/Component |
| Action | Philips Medical Systems (Cleveland), Inc. sent a Customer Information letter dated June 14, 2016, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. No action is required of the customer for this issue. Systems that may have been manufactured with these stainless steel fasteners still meet the safety specifications required for the adjustment cradle and may continue to be used clinically. For further information or support customers were instructed to call 1-800-722-9377. For questions regarding this rec |
| Quantity | 89 |
| Distribution | Worldwide distribution to Belgium, China, Egypt, Germany, India, Korea, Republic of, Myanmar, Nigeria, Peru, Russian Federation, Rwanda, Singapore, Spain, Sweden, Taiwan, Thailand, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc., Jan 9, 2004 |