MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
FDA device recall Z-0019-2014 · posted 2013-10-17 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- A pinch point at the end of the table top can cause injury.
- Action taken
- Field Safety Notice (FSN 72800601_72800603, will be sent to all US consignees via certified mail. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.
- Root cause
- Use error
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 326
- Distribution
- Worldwide Distribution-USA including the states of AL, AR, CA, FL, GA, IL, IN, KY, MS, NC, NJ, NV, NY, OH, PA, and VA; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Boliv
- Date initiated
- 2013-07-22
- Date posted
- 2013-10-17
- Date terminated
- 2014-09-25
- Location
- Cleveland, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS MODEL MX 16 SLICE CT SYSTEM (K083498) | Philips Medical Systems (Cleveland), Inc. | 2008-12-17 |