Recall Z-2245-2012— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2012-08-03, terminated 2015-07-23. It names 3 FDA 510(k) clearances: K033357, K033326, K012009. Product: The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems that are 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 analysis and display equipment, patient, and equipment supports, components and accessories. Reason: The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-03
- Terminated
- 2015-07-23
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
3 on FDA's record- K033357 — ACQSIM-MULTISLICE-CT, MODEL 453567042271
- K033326 — PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
- K012009 — MX8000 IDT CT SYSTEM
K-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
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems that are 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 analysis and display equipment, patient, and equipment supports, components and accessories
Reason for recall
The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.
Data sourced from openFDA. This site is unofficial and independent of the FDA.