Recall Z-1352-2016— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2016-02-05, terminated 2018-07-02. It names one FDA 510(k) clearance: K060937. Product: Brilliance iCT 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. Reason: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-05
- Terminated
- 2018-07-02
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Brilliance iCT 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
Reason for recall
The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Data sourced from openFDA. This site is unofficial and independent of the FDA.