Reported Jul 4, 2018 · Terminated
Ingenuity Core128/Elite China 728324
Philips Medical Systems (Cleveland) Inc.
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 (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Ingenuity Core128/Elite China 728324
- Lot codes and dates
8 of 8 products
Products covered by this recall # Barcodes Product as published 1 00884838059863(01)00884838059863(21)336856, Serial Number: 336856 2 00884838059863UDI: (01)00884838059863(21)336851, Serial Number: 336851 3 00884838059863UDI: (01)00884838059863(21)336849, Serial Number: 336849 4 00884838059863UDI: (01)00884838059863(21)336852, Serial Number: 336852 5 00884838059863UDI: (01)00884838059863(21)336853, Serial Number: 336853 6 00884838059863UDI: (01)00884838059863(21)336855, Serial Number: 336855 7 00884838059863UDI: (01)00884838059863(21)336854, Serial Number: 336854 8 00884838059863UDI: (01)00884838059863(21)336850, Serial Number: 336850
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
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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