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.
FDA Recall Z-1648-2015 · Posted 2015-05-22
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2015-03-16
Date Terminated2017-02-22
Product Quantity153 units total
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.
Firm Action
On 3-18-2015 the firm sent Urgent Field Safety Notices to their customers.
Root Cause
Employee error
Distribution Pattern
Distributed in China.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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