Reported Feb 21, 2024 · Ongoing
CombiDiagnost R90 1.1 (709031)
Philips Medical Systems
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 MEDICAL SYSTEMS · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- CombiDiagnost R90 1.1 (709031)
- Lot codes and dates
- ModelR90 1.1 (709031)
- UDI DI
00884838101456Software version 1.1.1 or higher
- Serial Numbers
130 of 130 codes
100010041000100510001006100010081000100910001010100010111000101210001013100010181000102010001022100010241000102610001027100010281000102910001030100010311000103210001035100010361000104310001044100010451000104610001047100010481000104910001050100010511000105210001053100010541000105510001056100010571000105810001059100010601000106110001062100010631000106410001065100010661000106710001068100010691000107010001071100010721000107310001074100010751000107610001077100010781000107910001080
- Amount recalled
- 130 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
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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