CLASS II ONGOING Device recall · Reported 29 May 2024 · FDA Enforcement Report
Panorama HFO- Magnetic Resonance recalled by Philips North America
Philips North America is recalling Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated, distributed nationwide in the US. The recall was initiated on 3 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1855-2024
- FDA event ID
- 94508
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 May 2024
- FDA classified
- 17 May 2024
- Reported
- 29 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 3 May 2024 | Recall initiated by company | |
| 17 May 2024 | Classified by FDA | +14 days |
| 29 May 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Questions about this recall
Why was it recalled?
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Which lots are affected?
UDI-DI: (1) 782152 N/A (2) 782110 (01)00884838099364(21) Serial Numbers: Serial Number 37019 37067 37149 37188 37184 37034 37036 37058 37167 37173 37183 37195 37197 37009 37011 37013 37020 37027 37031 37050 37055 37080 37093 37100 37121 37127 37132 37137 37141 37143 37150 37157 37170 37180 37193 37194 37023 37044 37066 37071 37106 37124 37160 37175 37182 37192 37022 37068 37082 37129 37134 37145 37156 37171 37181 37187 19083 37161 37178 37088 37024 37098 37135 37139 37176 37153 37060 37116 37196 37015 37073 37109 37122 37133 37162 37185 37026 37096 37177 37002 37012 37017 37029 37039 37041 37047 37048 37052 37053 37056 37077 37083 37084 37086 37087 37095 37102 37104 37107 37110 37113 37120 37123 37125 37128 37130 37136 37142 37158 37159 37163 37165 37168 37189 37069 37174 37126
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
29 other products · FDA event 94508This product is part of a recall event; the main page for the event is Achieva 3.0T recalled by Philips North America.
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