Recall Z-1415-2018— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2018-02-08, terminated 2020-04-09. It names one FDA 510(k) clearance: K012009. Product: Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system Product Usage: 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.. Reason: Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-08
- Terminated
- 2020-04-09
- 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 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system Product Usage: 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Reason for recall
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Data sourced from openFDA. This site is unofficial and independent of the FDA.