MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body c
FDA device recall Z-2386-2012 · posted 2012-09-14 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
- Action taken
- An "Urgent Medical Device Correction" Field Safety Notice dated August 24, 2012 was sent to all US consignees via certified mail. The problem was described and recommended actions were provided. Philips Key Market representatives distributed the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Orders. US Customer contact number: 1 800-722-9377.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 328 units
- Distribution
- Worldwide distribution, Nationwide (US) including the states AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, and VA and the countries of Albania, Argentina, Australia, Belgium, Brazil, Chile, Chin
- Date initiated
- 2012-08-24
- Date posted
- 2012-09-14
- Date terminated
- 2013-08-28
- 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 MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 (K091195) | Philips Medical Systems (Cleveland), Inc. | 2009-05-27 |
| PHILIPS MODEL MX 16 SLICE CT SYSTEM (K083498) | Philips Medical Systems (Cleveland), Inc. | 2008-12-17 |