Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intend
FDA device recall Z-2709-2014 · posted 2014-09-26 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.
- Action taken
- Customers will be contacted by a field service technician with the field correction order. The firm will install the new labeling to the device.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 364
- Distribution
- Worldwide Distribution -- AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, and WI; and, countries of Singapore, New Zealand, India, Australia, Korea, Japan, Korea, China, India,
- Date initiated
- 2005-12-27
- Date posted
- 2014-09-26
- Date terminated
- 2015-11-06
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM (K033326) | Philips Medical Systems, Inc. | 2003-10-29 |
| MX8000 V5.0 CT SYSTEM (K010817) | Philips Medical Systems (Cleveland), Inc. | 2001-06-15 |