Recall Z-3198-2024— Philips North America Llc
Class II · Ongoing
Class II FDA medical device recall by Philips North America Llc, initiated 2024-09-03. It names 3 FDA 510(k) clearances: K213516, K212673, K193215. Product: Ingenia Ambition 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: 782109. Reason: 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..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-03
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
3 on FDA's record- K213516 — Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
- K212673 — MR 5300
- K193215 — Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Ingenia Ambition 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: 782109
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.