Reported May 29, 2024 · Ongoing
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.…
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
- Model Number (REF)781350
- Lot codes and dates
- UDI-DI(1) 782152 N/A (2) 782110 (01)00884838099364(21)
- Serial NumbersSerial Number
117 of 117 codes
370193706737149371883718437034370363705837167371733718337195371973700937011370133702037027370313705037055370803709337100371213712737132371373714137143371503715737170371803719337194370233704437066370713710637124371603717537182371923702237068370823712937134371453715637171371813718719083371613717837088
- Amount recalled
- 118 units
This recall covers 32 products
The agency filed one notice per product. You are reading one of them; the other 31 are below.
19 more are in the archive.
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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