Recall Z-0422-2007 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound, Inc.
iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic)
| Date | Feb 17, 2007 (initiated Nov 2, 2006) |
| Status | Terminated |
| Reason | Acoustic output intensity may exceed maximum specified limits and the patient contact temperature may exceed 43 degree C (when the system is used with the S12-4 transducer in CW-mode) |
| Root cause | Other |
| Action | On 11/2/06 the firm sent a letter dated October 31, 2006 to their customers. The letter explains the problem and states that new software is being released and will be available sometime in November. Customer service representatives will visit consignees to upgrade their units. The firm later determined they sent letters out to consignees that did not have affected units. Those consignees will be notified the week of 11/20/06 to disregard the previous letter. |
| Quantity | 619 domestic units, 706 international units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030455 | BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc., Mar 13, 2003 |