medical Class II Updated 2021-09-15

Philips North America Llc recalls Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electric

Recalled Product

Ingenia 1.5T Evolution-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 Model: 781315

Hazard / Issue

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model: 78135 Serial Number Unique Device Identifier (UDI#) 61019 (01)00884838099715 61028 (01)00884838099715 61001 (01)00884838099715 61004 (01)00884838099715 61023 (01)00884838099715 61008 (01)00884838099715 61026 (01)00884838099715 61034 (01)00884838099715 61046 (01)00884838099715 61025 (01)00884838099715 61035 (01)00884838099715 61042 (01)00884838099715 61040 (01)00884838099715 61041 (01)00884838099715(21)61041 61007 (01)00884838099715 61014 (01)00884838099715 61018 (01)00884838099715 61000 N/A 61003 (01)00884838099715 61002 N/A 61006 N/A 61009 N/A 61013 N/A 61017 (01)00884838099715(21)61017 61032 (01)00884838099715(21)61032 61015 N/A 61005 (01)00884838099715 61020 (01)00884838099715 61043 (01)00884838099715 61029 (01)00884838099715 61030 (01)00884838099715 61033 (01)00884838099715(21)61033 61052 (01)00884838099715(21)61052 61064 (01)00884838099715(21)61064 61027 (01)00884838099715 61016 (01)00884838099715 61022 (01)00884838099715 61044 (01)00884838099715 61050 (01)00884838099715 61047 (01)00884838099715(21)61047 61053 (01)00884838099715(21)61053 61049 (01)00884838099715(21)61049
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