Recalls / —
—#137291
Product
Brilliance CT 10 Air. 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.
- FDA product code
- JAK — System, X-Ray, Tomography, Computed
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K012009
- Affected lot / code info
- System Code #, 728256, Serial #, 2448, 3145, 3212, 3213, 3276, 3278, 280, 3307, 3309, 3317, 3336, 30003, 30008, 30017, 30021, 30022, 30036 & 30047.
Why it was recalled
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 (FDA determination)
Employee error
Action the firm took
On 3-18-2015 the firm sent Urgent Field Safety Notices to their customers.
Recalling firm
- Firm
- Philips Medical Systems (Cleveland) Inc
- Address
- 595 Miner Rd, Cleveland, Ohio 44143-2131
Distribution
- Distribution pattern
- Distributed in China.
Timeline
- Recall initiated
- 2015-03-16
- Posted by FDA
- 2015-05-22
- Terminated
- 2017-02-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #137291. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.