Reported Jul 3, 2024 · Ongoing
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva…
Philips North America LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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?
- SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems
- Model Numbers
453567141882453567141883. Coils may
- be included in kits with Mode Numbers989603014351 & 989603014352
- Lot codes and dates
- UDI-DIN/A. 1. Model Number 453567141882
- Serial Numbers
13714114514715718188191911972512913013203563603643663713939440408418428434446464468470471472557951243523033283154432412215358300427175421300202352432429469313365. 2. Model Number 453567141883
- Serial Numbers
1131341371401521531741961972020420522823423526374041424470929395805216224116588247964615. 3. Model Number 989603014351
- Serial Numbers
IBA_CD_2012629240530203408494638. 4. Model Number 989603014352
- Serial Numbers
592 of 592 codes
28884374389511691204126210035001197115092110631107109811201138113311391155117011561177118311871190120512121298124412471269126612741299131512834578441181122412581257124910734404654291289125233436398092810921323709614192540
- Amount recalled
- 729 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Potential for coils to heat up and harm patients (burn).
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
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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