Philips North America Llc: SmartPath to dStream for 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, b

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Maldives, Mauritius, Mexico, Morocco, Netherlands, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Quantity: 32 units Lot/code info: Model UDI-DI: 782112 (01)00884838098886(21); 781260 (01)00884838095076(21). Serial Numbers; 8876 10190 10521 13021 13023 18520 18892 18942 20159 21127 21158 21513 21726 21803 22027 22048 22093 22247 30054 30273 32250 32355 32412 32419 32469 32539 32724 32827 33371 33639 39070 75067

UPC codes

00884838098886, 00884838095076

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.