The Recall Desk
HighFDA (Devices)·Z-0462-2023·Announced 2022-12-14

Philips MR 7700 System Recalled for Gradient Coil Fire Risk

Philips is recalling 566 MR 7700 MRI systems nationwide. The gradient coil in these systems may overheat and produce fire or smoke.

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: This FDA Class II medical device recall involves a potential fire and smoke hazard from gradient coil overheating, with no reported injuries or hospitalizations, meeting the criteria for 'High' as a risk-of-harm product where injury has not been reported.

Plain-English summary

Philips North America LLC is recalling 566 Philips MR 7700 Magnetic Resonance Imaging (MRI) systems, Model Number 782120, distributed nationwide in the United States.

The gradient coil component in these systems may act as a heat source with potential to produce smoke and/or fire. This creates a fire hazard to patients, healthcare workers, and medical facilities where the systems are installed.

Affected systems are Model 782120 with UDI-DI 00884838104112. Healthcare providers should contact Philips North America LLC for information about remediation steps, including inspection, repair, or replacement options.

The recalled product

Product
Philips MR 7700 System, Model Number 782120
Manufacturer
Philips North America Llc
Category
Medical Device — Magnetic Resonance Imaging System
Hazard
  • fire
  • smoke

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 (2)

  • Model 782120: UDI-DI: 00884838104112
  • Serial Numbers: 65005 65006 65007 65008

Distribution

Distributed nationwide across the United States.

Related recalls

Same category