Recall Z-0923-05 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound, Inc.
Envisor, M2540 Diagnostic Ultrasound System
| Date | Jun 22, 2005 (initiated May 13, 2005) |
| Status | Terminated |
| Reason | A defect in the software allows incorrect measurement results to be entered into the system's built-in report. |
| Root cause | Other |
| Action | On May 13, 2005 the firm mailed a letter to their customers advising of the problem and that a local representative will visit each site to perform a software upgrade. |
| Quantity | 194 |
| Distribution | Units were distributed nationwide to hospitals and medical centers and internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014191 | M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 Philips Medical Systems, Jan 7, 2002 |