Reported May 29, 2024 · Ongoing
Achieva 1.5T- 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?
- Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as
- a diagnostic device Model Number (REF)(1) 781296 (2) 781343
- Lot codes and dates
- UDI-DI(01)00884838004108(21) Serial Number(2)
1,382 of 1,382 codes
323073345433668323023240132679326993281432894329133292332974330023307133073332243322733386333873348533488334933350233503335183355133571336833370433713337463230632475335693207532797323263317533519333643370232853321003211232186321933221632223322433227632277322783230132304323393235832367323773248432487
- Serial NumbersSerial Number
202 of 202 codes
720187202072104721377213872146721577216072170721717217972183721857219072200722237223372238722517226972013721117211272113722317223572270722717227272273723157207972083721097212072122721237212472126721397214072141721427214772150722477200772156721017211672117721807219772267721897220472325723277200872080
- UDI-DI(01)00884838004108(21) Serial Number
- Amount recalled
- 1585 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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