Recall Z-0987-2007 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Medical Systems
HD11XE Diagnostic Ultrasound System
| Date | Jul 3, 2007 (initiated Apr 25, 2007) |
| Status | Terminated |
| Reason | Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical measurement or calculation. If the user exits an imaging mode while Active Annotation is in use, the system can enter an undefined state where the image scale calibration may not match the scale of the on-screen measurements and graphics and possib |
| Root cause | Other |
| Action | On 04/25/2007 firm sent letters dated 04/23/2007 to consignees informing them of the issue and that a new software release to correct the issue became available 04/19/2007. The firm's Field Service Representatives will contact consignees to install the new software at no charge to the consignee. |
| Quantity | 219 units in US and 347 units distributed internationally |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043535 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc., Jan 6, 2005 |