Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by comp
FDA device recall Z-1651-2015 · posted 2015-05-22 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
- Action taken
- On 3-18-2015 the firm sent Urgent Field Safety Notices to their customers.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 153 units total
- Distribution
- Distributed in China.
- Date initiated
- 2015-03-16
- Date posted
- 2015-05-22
- Date terminated
- 2017-02-22
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MX8000 IDT CT SYSTEM (K012009) | Marconi Medical Systems, Inc. | 2001-09-13 |