The Recall Desk
HighFDA (Devices)·Z-2417-2021·Announced 2021-09-15

Philips MRI System Tabletop May Not Fully Move in Manual Mode

Philips Ingenia 3.0T-a MRI systems have an issue where the tabletop may not completely move in or out during manual operation. This could delay patient evacuation from the scanner bore and postpone medical treatment.

What this means for you

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 recall with no reported illnesses or injuries. The hazard involves potential delay in patient evacuation and treatment due to a mechanical malfunction, which qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling certain Ingenia 3.0T-a Magnetic Resonance Imaging (MRI) systems, models 781342 and 781377. The recall was issued by the FDA as a Class II recall with recall number Z-2417-2021.

The tabletop component may not completely move in or out during manual mode operation. This malfunction could result in delays in patient evacuation from the scanner bore and potential delays in medical treatment.

The affected systems were distributed worldwide, including the United States. The recall involves 964 units of model 781342 and 422 units of model 781377.

The recalled product

Product
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging / MRI
Hazard
  • equipment-malfunction
  • patient-evacuation-delay

Distribution

Distributed nationwide across the United States.

Related recalls

Same category