Home / Recalls / Philips North America Llc / Z-3200-2024

Z-3200-2024 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

FDA device recall Z-3200-2024 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: 33 units.

Recall Details

Product Type: Devices
Report Date: Oct 2, 2024
Initiation Date: Sep 3, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 33 units

Product Description

Ingenia Elition X- 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) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 782136

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: 782151 N/A; 782119 (01)00884838104129(21); 781358 (01)00884838088115(21); 782107 (01)00884838098336(21); 782136 (01)00884838108608(21) Serial Numbers: 26500 26505 28502 28509 45393 45467 45599 62029 62041 62051 62052 62061 62066 62070 62071 62081 62082 62083 62091 62103 62111 62113 62114 62120 62126 62129 62147 62148 62186 62187 62188 66001 66002

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-3200-2024
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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