MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography
FDA device recall Z-0190-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- "The orientation of images is displayed incorrectly. When operator chooses gantry on the right side from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient position picture and text is not consistent. "L" and "R" of scan images are reversed and this is not consistent with the patient actual position. "When a surview which is longe
- Action taken
- Philips is informing the consignees of this issue through a Field Safety Notice (FSN) 72800615 on October 09, 2014. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, A Field Service Engineer will contact each site to schedule a time to install the software update.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 708
- Distribution
- Domestic Distribution: AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, ND, NJ, NV, NY, OH, PA, PR, SC, TN, and VA. Foreign distribution: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, B
- Date initiated
- 2014-10-09
- Date posted
- 2014-12-16
- Date terminated
- 2015-07-02
- Location
- Cleveland, OH
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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 |