Reported May 29, 2024 · Ongoing
Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a…
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?
- Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as
- a diagnostic device Model Number (REF)
(1) 781283(2) 781346
- Lot codes and dates
- UDI-DI1. (01)00884838068469(21) 2. (01)00884838009806(21) (1)
- Serial Numbers(2)
73 of 73 codes
39011390563908439102898910126390983902239079390263909739108390823900639013390413908139092390963910039010390283903239066390863909439095391073900139004390643907439007390123902939030390343903639038390393904039042390543905739058390593906239071390753907739080390833908839089390913909939105390933905339023
66 of 66 codes
1805283618415100157500852438727101721018910545187377500275003750047501555478059876788428883888688978946898189901006018001187107500975092750957509975100827610194105128069831285201000610048185887500075001750057504975087828983678714874010539750118351839887827506887567501018505
- Amount recalled
- 140 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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