Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
Reported: May 22, 2024 Initiated: April 22, 2024 #Z-1830-2024
Product Description
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
Reason for Recall
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 19 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, KS, MS, NH and the countries of Austria, Croatia, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Sweden, Switzerland, Thailand, United Kingdom.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117. Recalled by Philips North America Llc. Units affected: 19 units.
Why was this product recalled? ▼
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2024. Severity: Moderate. Recall number: Z-1830-2024.
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