Z-1830-2024 Class II Ongoing
FDA device recall Z-1830-2024 was initiated by Philips North America Llc on Apr 22, 2024 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 19 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- Apr 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
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
Distribution Pattern
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.
Code Information
UDI-DI: (01)00884838099739(21) Serial Numbers: 42029 42217 42246 71044 71774 85146 85645 85663 85664 85668 85677 85680 85681 85685 85700 85704 85705 85706 85713
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1830-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026