Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Reported: May 13, 2020 Initiated: April 6, 2020 #Z-1921-2020
Product Description
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Reason for Recall
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 19
- Distribution
- Worldwide distribution including one unit distributed to Iowa.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848. Recalled by Philips North America, LLC. Units affected: 19.
Why was this product recalled? ▼
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2020. Severity: Moderate. Recall number: Z-1921-2020.
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