PlainRecalls
FDA Devices Moderate Class II Terminated

Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311

Reported: May 13, 2020 Initiated: April 6, 2020 #Z-1922-2020

Product Description

Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311

Reason for Recall

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

Details

Units Affected
2
Distribution
Worldwide distribution including one unit distributed to Iowa.
Location
Andover, MA

Frequently Asked Questions

What product was recalled?
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311. Recalled by Philips North America, LLC. Units affected: 2.
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-1922-2020.