Philips Ingenia Ambition X MRI Scanner Recalled Due to Loose Screws
Philips is recalling 63 units of the Ingenia Ambition X MRI scanner due to loose screws in the IRF carrier assembly that may block the imaging tabletop and potentially delay diagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with a potential mechanical defect (loose screws in the IRF carrier assembly) that could block the imaging tabletop and delay diagnosis. No injuries or illnesses have been reported; the hazard is theoretical rather than actualized.
Plain-English summary
Philips North America LLC is recalling 63 units of the Ingenia Ambition X, a diagnostic imaging device used to obtain cross-sectional images of the head, body, and extremities via magnetic resonance imaging (MRI). The affected units are identified by 63 specific serial numbers and have been distributed worldwide, including throughout the United States and over 50 countries.
The recall was initiated because screws in the Integrated Radio Frequency (IRF) Carrier assembly may come loose and protrude beyond the device's surface. These loose screws could interfere with other moving parts of the scanner and potentially block the horizontal tabletop.
If the tabletop becomes blocked, it may delay diagnosis and prevent proper patient positioning. Patients left on a blocked tabletop inside the scanner bore may experience anxiety from an unplanned extended duration of confinement.
The recalled product
- 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
- Manufacturer
- Philips North America Llc
- Affected units
- 63
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: (01)00884838098350(21) Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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