Recall Z-1821-2012 ยท IXR Table, Radiographic, Tilting
Philips Healthcare Inc.
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
| Date | Jun 18, 2012 (initiated May 11, 2012) |
| Status | Terminated |
| Reason | If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be execut |
| Root cause | Device Design |
| Action | Philips sent an Urgent - Field Safety Notice letter dated May 11, 2012 to their affected customers. The letter identified the affected product, what the issues are, under what circumstances they may occur and the actions to be taken to avoid or minimize the occurrence of the issue Philips plans to supply an Addendum to the Instruction for Use. A Philips Service Engineer will contact the affected customers as soon as the Field Action Kit is ready to be implemented. For questions contact your local Philips representative: Technical Support Line 1-800-722-9377. |
| Quantity | 6 |
| Distribution | 6 US customers |
| FDA record | Open on fda.gov |