medical Class II Updated 2024-10-02

Philips North America Llc recalls Ingenia 1.5T -For use as a diagnostic device to obtain cross

Recalled Product

Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140

Hazard / Issue

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model UDI-DI: 782115 (01)00884838099043(21); 782101 (01)00884838098275(21); 782140 (01)00884838108646(21) Serial Numbers: 45601 61291 61312 61315 61328 61336 61337 61339 61348 61349 61351 61354 61355 61356 61357 61359 61360 61361 61362 61363 61364 61367 61371 61373 61374 61375 61376 61377 61378 61380 61383 61384 61394 61395 61397 61403 61404 61406 61407 61412 61415 61416 87645 87648 87649 87651 87654 87655
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