Z-1648-2015Class II
Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cross-sectional images...
Philips North America LLC / initiated 2015-03-16 / Terminated / root cause: manufacturing process
Philips Medical Systems (Cleveland) Inc began a recall of Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1648-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Philips North America LLC
- Product
- Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
- Product code
- JAK System, X-Ray, Tomography, Computed
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- Employee error
- Action
- On 3-18-2015 the firm sent Urgent Field Safety Notices to their customers.
- Quantity in commerce
- 153 units total
- Distribution
- Distributed in China.
- Product codes and lots
- System Code #, 728243, Serial #, 7039
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1647-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1648-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1649-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1650-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1651-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1652-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1653-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1654-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1655-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1656-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1657-2015 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.