Brilliance 16 Slice (Power), Model 728240 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
Reported: December 12, 2018 Initiated: October 18, 2018 #Z-0545-2019
Product Description
Brilliance 16 Slice (Power), Model 728240 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
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 6,343 units in total
- Distribution
- US Nationwide Distribution
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Brilliance 16 Slice (Power), Model 728240 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. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 6,343 units in total.
Why was this product recalled? ▼
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 12, 2018. Severity: Moderate. Recall number: Z-0545-2019.
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