Philips MR 5300 MRI System Recalled for Loose Assembly Screws
Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient 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: This is an FDA Class II recall with a mechanical defect that poses patient safety and operational risks. No illnesses or injuries have been reported. The defect could block equipment movement and delay diagnosis. Per the rubric, recalls involving documented risk-of-harm without reported injuries are scored as High.
Plain-English summary
Philips North America LLC is recalling 68 MR 5300 diagnostic MRI systems. The devices have a defect in the Integrated Radio Frequency (IRF) Carrier assembly.
The IRF Carrier assembly contains screws that may come loose and protrude beyond the device surface. Loose screws could interfere with other moving parts in the MRI system, potentially blocking the horizontal patient tabletop.
If the tabletop becomes blocked during operation, this could delay patient diagnosis. Additionally, if a patient is on the tabletop when it becomes blocked, the patient may be left inside the bore for longer than anticipated, which could cause anxiety. The affected systems are distributed worldwide with specific serial numbers identified by the manufacturer.
The recalled product
- Product
- MR 5300 - 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: 782110
- Manufacturer
- Philips North America Llc
- Affected units
- 68
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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