HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
FDA device recall Z-0178-05 · posted 2004-11-05 · Terminated
Recall details
- Recalling firm
- Philips Ultrasound, Inc.
- Reason for recall
- Potential for device to cause burning of the skin.
- Action taken
- On 9/6/04 the firm sent a certified return receipt letter to customers advising of the issue and informing that a service representative will visit to install new software to reduce thermal output.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 333 domestic units, 29 demos, 704 international units
- Distribution
- Units were distributed to medial facilities, hospitals, and veterinarians worldwide. Countries include Africa, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia,
- Date initiated
- 2004-09-10
- Date posted
- 2004-11-05
- Date terminated
- 2006-02-09
- 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 |
|---|---|---|
| SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM (K002185) | Medison America, Inc. | 2000-08-01 |