Envisor, M2540 Diagnostic Ultrasound System
FDA device recall Z-0923-05 · posted 2005-06-22 · Terminated
Recall details
- Recalling firm
- Philips Ultrasound, Inc.
- Reason for recall
- A defect in the software allows incorrect measurement results to be entered into the system's built-in report.
- Action taken
- On May 13, 2005 the firm mailed a letter to their customers advising of the problem and that a local representative will visit each site to perform a software upgrade.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 194
- Distribution
- Units were distributed nationwide to hospitals and medical centers and internationally.
- Date initiated
- 2005-05-13
- Date posted
- 2005-06-22
- Date terminated
- 2008-05-09
- 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 |
|---|---|---|
| M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 (K014191) | Philips Medical Systems | 2002-01-07 |