PlainRecalls
FDA Devices Moderate Class II Terminated

Brilliance CT 6 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.

Reported: June 3, 2015 Initiated: March 16, 2015 #Z-1655-2015

Product Description

Brilliance CT 6 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.

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.

Details

Units Affected
153 units total
Distribution
Distributed in China.
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled?
Brilliance CT 6 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.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 153 units total.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 3, 2015. Severity: Moderate. Recall number: Z-1655-2015.