iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic)
FDA device recall Z-0422-2007 · posted 2007-02-17 · Terminated
Recall details
- Recalling firm
- Philips Ultrasound, Inc.
- Reason for recall
- 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)
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 619 domestic units, 706 international units
- Distribution
- Worldwide
- Date initiated
- 2006-11-02
- Date posted
- 2007-02-17
- Date terminated
- 2009-07-14
- 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 |
|---|---|---|
| BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM (K030455) | Philips Ultrasound, Inc. | 2003-03-13 |