OmniDiagnost
FDA device recall Z-1665-2009 · posted 2009-09-24 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch
- Action taken
- A Customer Notification letter describing the potential grid switch failure and actions planned by Philips to correct the problem will be sent to all users of the affected systems during the week of July 6, 2009.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 28 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-07-06
- Date posted
- 2009-09-24
- Date terminated
- 2011-12-16
- 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 |
|---|---|---|
| PHILIPS OMNIDIAGNOST (K982993) | Philips Medical Systems, Inc. | 1998-09-29 |