FDAFDA · Food and drugs·Recall number Z-1669-2023
Intelli-C, Left side suspended Tabletop, REF: 03400010
Published June 7, 2023 · Recall initiated: April 27, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- NRT X-RAY A/S
- Distributor
- US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.
- Lot
- UDI-DI:05713464000121/Serial Numbers: 647009, 651002, 651006, 666009, 682003
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Denmark
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