Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 2
FDA device recall Z-0865-05 · posted 2005-06-03 · Terminated
Recall details
- Recalling firm
- Philips Ultrasound, Inc.
- Reason for recall
- The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DPW
- Quantity affected
- 1225 units
- Distribution
- The units were distributed worldwide. Domestic distribution included hospitals and medical centers.
- Date initiated
- 2005-05-06
- Date posted
- 2005-06-03
- Date terminated
- 2008-05-21
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VASCULAR ASSIST (K002186) | Huntleigh Healthcare, Inc. | 2001-05-02 |