Recall Z-0865-05 ยท DPW Flowmeter, Blood, Cardiovascular
Philips Ultrasound, Inc.
Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01)
| Date | Jun 3, 2005 (initiated May 6, 2005) |
| Status | Terminated |
| Reason | The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI. |
| Root cause | Other |
| Action | On May 6, 2005 the firm mailed a letter, via return receipt requested, to customers. The letter advised of the problem, and provided instructions to create new low power presets. The letter also advised that software would be issued on/before November 2005. |
| Quantity | 1225 units |
| Distribution | The units were distributed worldwide. Domestic distribution included hospitals and medical centers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002186 | VASCULAR ASSIST Huntleigh Healthcare, Inc., May 2, 2001 |