FDAFDA · Food and drugs·Recall number Z-1921-2020
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Published May 13, 2020 · Recall initiated: April 6, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Philips North America, LLC
- Distributor
- Worldwide distribution including one unit distributed to Iowa.
- Lot
- Serial #s 100193, 100408, 100457, 100783, 100356, 100113, 100380, 100318, 100848, 100112, 100742, 100447, 100685, 100375, 100449, 100659, 100158, 100398 Additional serial number as of 5/22/20: 100117
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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