Philips Healthcare Brilliance iCT computed tomography x-ray system
Reported: January 17, 2018 Initiated: November 8, 2017 #Z-0331-2018
Product Description
Philips Healthcare Brilliance iCT computed tomography x-ray system
Reason for Recall
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 702
- Distribution
- 107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Philips Healthcare Brilliance iCT computed tomography x-ray system. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 702.
Why was this product recalled? ▼
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2018. Severity: Moderate. Recall number: Z-0331-2018.
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