Home / Recalls / Philips North America Llc / Z-3203-2024

Z-3203-2024 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

FDA device recall Z-3203-2024 was initiated by Philips North America Llc on Sep 3, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 32 units.

Recall Details

Product Type: Devices
Report Date: Oct 2, 2024
Initiation Date: Sep 3, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 32 units

Product Description

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, body or extremities, in any orientation. (REF) Numbers: 1) 782112; 2) 781260

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 Pattern

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 Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam.

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-3203-2024
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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